| Primary | Stage 1: Change From Baseline in TB Bacterial Load in Sputum as a Measure of Early Bactericidal Activity (EBA) | Bacterial load in sputum at each collection time point was measured by CFU counts on agar media culture. EBA was determined by the rate of decline per day in log10CFU/mL during the first 14 days of treatment. Change from baseline in log 10 CFU was calculated as post-baseline minus baseline. A larger EBA in positive direction indicates a better drug effect. | MITT Analysis Set included randomized participants who were agar media culture positive at baseline (either at Day -2 or at Day -1, or both), received any dose of IMP, and had at least one post-baseline CFU count value. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Error | sputum log10CFU/mL | | Baseline to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 90 mg OPC-167832 | Participants received OPC-167832, 90 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG004 | Stage 1: RHEZ | Participants received a single dose of RHEZ (each tablet containing 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol), orally, QD from Day 1 through Day 20. |
| | Units | Counts |
|---|
| Participants | - OG00014
- OG00110
- OG00213
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.93± 0.98
- OG001-2.12± 1.01
- OG002-2.08± 0.75
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | EBA Ratio | 0.689 | | | 2-Sided | 95 | 0.485 | 0.939 | | | The confidence interval for the EBA ratio is estimated using Fieller's method. | | Superiority | | | | | | |
|
| Primary | Stage 1 and Stage 2: Maximum (Peak) Plasma Concentration (Cmax) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 | Stage 1: 90 mg OPC-167832 |
|
| Primary | Stage 1 and Stage 2: Cmax at Steady-state (Cmax,ss) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | |
|
| Primary | Stage 1 and Stage 2: Time to Cmax (Tmax) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 | Stage 1: 90 mg OPC-167832 |
|
| Primary | Stage 1 and Stage 2: Tmax of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 |
|
| Primary | Stage 1 and Stage 2: Area Under the Concentration-Time Curve (AUC) From Time Zero to Time t (the Last Observable Concentration, Here t=24) (AUC0-24), for OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | nanogram.hour per milliliter (ng*h/mL) | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 1 and Stage 2: AUC Calculated Over the Dosing Interval at Steady-state (AUCτ) for OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 1 and Stage 2: Terminal-phase Elimination Half-life (t1/2,z) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | T1/2,z is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. Half-life (T1/2) is determined in the terminal phase after drug administration, which is calculated from the relationship T1/2 = ln2/λz where λz is the terminal-phase slope obtainable from non-compartmental analysis (NCA). The values reported for this outcome measure (OM) are estimates and not actual observed data. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 1 and Stage 2: Apparent Clearance From Plasma at Steady-state (CLss/F) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | mL/minute (min) | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 1 and Stage 2: Accumulation Ratio of Cmax (RCmax) for OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ratio | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | |
|
| Primary | Stage 1 and Stage 2: Accumulation Ratio of AUC (RAUC) for OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants available for analysis. | Posted | | Mean | Standard Deviation | ratio | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | |
|
| Primary | Stage 1 and Stage 2: Cmax Normalized to Dose (Cmax/Dose) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 2: AUCτ Normalized to Dose (AUCτ/Dose) of OPC-167832 When Administered Alone (Stage 1) and in Combination With Delamanid, and BDQ (Stage 2) | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng*h/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 3 mg OPC-167832 | Participants received OPC-167832, 3 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | |
|
| Primary | Stage 2: Cmax of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: Cmax,ss of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: Tmax of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: Tmax of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: AUC0-24 of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng.h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: AUCτ of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: T1/2,z of Delamanid | T1/2,z is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. Half-life (T1/2) is determined in the terminal phase after drug administration, which is calculated from the relationship T1/2 = ln2/λz where λz is the terminal-phase slope obtainable using the NCA method. The values reported for this OM are estimates and not actual observed data. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
|
| Primary | Stage 2: CLss/F of Delamanid From Plasma | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | mL/min | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
| |
| Primary | Stage 2: RCmax of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ratio | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: RAUC of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ratio | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Cmax/Dose of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: AUCτ/Dose of Delamanid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng*h/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Cmax of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Cmax,ss of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Tmax of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Tmax of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: AUC0-24 of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: AUCτ of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: T1/2,z of Bedaquiline | T1/2,z is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. Half-life (T1/2) is determined in the terminal phase after drug administration, which is calculated from the relationship T1/2 = ln2/λz where λz is the terminal-phase slope obtainable using the NCA method. The values reported for this OM are estimates and not actual observed data. Hence, the value might not lie within the sampling timepoints provided in the timeframe. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: CLss/F of BDQ From Plasma | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | mL/min | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: Cmax/Dose of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 2: AUCτ/Dose of Bedaquiline | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | (ng*h/mL)/mg | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Primary | Stage 1 and Stage 2: Number of Participants With Treatment-emergent Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were all AEs which started after the start of randomized study drug treatment or if the event was continuous from baseline and was serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study therapy. | Safety Analysis Set included participants who were randomized and received any dose of IMP. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
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| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 90 mg OPC-167832 | |
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| Primary | Stage 1 and Stage 2: Number of Participants With Clinically Significant Changes in Vital Sign Values | | Safety Analysis Set included participants who were randomized and received any dose of IMP. Number analyzed is the number of participants with data available for analysis for each specified vital sign parameter. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 90 mg OPC-167832 | Participants received OPC-167832, 90 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 |
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| Primary | Stage 1 and Stage 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | | Safety Analysis Set included participants who were randomized and received any dose of IMP. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 1: 90 mg OPC-167832 | Participants received OPC-167832, 90 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG003 |
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| Secondary | Stage 1 and Stage 2: Change From Baseline in Lipoarabinomannan (LAM) in the Mycobacteria Growth Indicator Tube® (MGIT) System | LAM is a key component of the M. tuberculosis cell wall and the decline of sputum LAM concentrations has been shown to correlate closely with CFU decreases in sputum counted on agar media during the first 14 days of TB treatment. Sputum LAM concentration at each collection time point was measured using MGIT system. Baseline LAM was calculated as the log 10 of the average from Day -2 and Day -1 and the change from baseline in log10 was calculated as post-baseline minus baseline for each parameter. | MITT Analysis Set included randomized participants who were agar media culture positive at baseline (either at Day -2 or at Day -1, or both), received any dose of IMP, and had at least one post-baseline CFU count value. Overall number of participants analyzed is the number of participants with data available for analysis. As pre-specified in the protocol and SAP, for Stage 2 data for participants in RHEZ arm was not included in this analysis. | Posted | | Mean | Standard Deviation | log10 LAM picograms (pg)/ml | | Baseline to Day 14 | | | | ID | Title | Description |
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| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 1: 30 mg OPC-167832 | Participants received OPC-167832, 30 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 1 and Stage 2: Change From Baseline in Time to Detection (TTD) in the MGIT System | TTD is the time from start of inoculation of a sputum sample until a MGIT machine detects a positive signal during the 42-day incubation period. One TTD measurement, reported in days and hours was taken at each of the visits at Days -2, -1, 2, 4, 6, 8, 10, 12 and 14. TTD values were then calculated as "days + hours/24" to be used in deriving the analysis values of TTD. Each sample collected from Day -2 to Day 14 were inoculated for 42 days. Baseline TTD was derived using Day -2 and Day -1 MGIT culture with a pure positive result for Mycobacterium tuberculosis. Postbaseline TTD analysis values from Day 1 were derived based on the MGIT culture result as follows: If MGIT culture result was negative for MTB complex, TTD was set to 42 days; If the MGIT culture was pure positive for MTB, but the TTD took longer than 42 days, TTD was capped at 42 days. | MITT Analysis Set included randomized participants who were agar media culture positive at baseline (either at Day -2 or at Day -1, or both), received any dose of IMP, and had at least one post-baseline CFU count value. Overall number of participants analyzed is the number of participants with data available for analysis. As pre-specified in the protocol and SAP, for Stage 2 data for participants in RHEZ arm was not included in this analysis. | Posted | | Mean | Standard Deviation | days | | Day 1 to Day 14 of treatment period + 42 days of inoculation period (up to 56 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: 10 mg OPC-167832 | Participants received OPC-167832, 10 mg, orally, QD, from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Change From Baseline in TB Bacterial Load in Sputum as a Measure of EBA | Bacterial load in sputum at each collection time point was measured by CFU counts on agar media culture. EBA was determined by the rate of decline per day in log10CFU/mL during the first 14 days of treatment. Change from baseline in log 10 CFU was calculated as post-baseline minus baseline. A larger EBA in positive direction indicates a better drug effect. | MITT Analysis Set included randomized participants who were agar media culture positive at baseline (either at Day -2 or at Day -1, or both), received any dose of IMP, and had at least one post-baseline CFU count value. Overall number analyzed is the number of participants with data available for analysis. As pre-specified in the protocol and SAP, for Stage 2 data for participants in RHEZ arm was not included in this analysis. | Posted | | Mean | Standard Error | Sputum log10 CFU/mL | | Baseline to Day 14 | | | | ID | Title | Description |
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| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Plasma Concentration of Rifampin | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Mean | Standard Deviation | ng/mL | | 2 hours and 6 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: RHEZ | Participants received a single dose of RHEZ (each tablet containing 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol), orally, QD, from Day 1 through Day 20. |
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| Secondary | Stage 1: Plasma Concentration of Isoniazid | | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Mean | Standard Deviation | microgram per millilitre (ug/mL) | | 2 hours and 6 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: RHEZ | Participants received a single dose of RHEZ (each tablet containing 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol), orally, QD from Day 1 through Day 20. |
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| Secondary | Stage 2: Cmax of DM-6705 | DM-6705 is a metabolite of delamanid. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Cmax,ss of DM-6705 | DM-6705 is a metabolite of delamanid. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Tmax of DM-6705 | DM-6705 is a metabolite of delamanid. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1; Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: AUC0-24 for DM-6705 | DM-6705 is a metabolite of delamanid. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1; Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: T1/2,z of DM-6705 | T1/2,z is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. Half-life (T1/2) was determined in the terminal phase after drug administration, which was calculated from the relationship T1/2 = ln2/λz where λz is the terminal-phase slope obtainable using the NCA method. The values reported for this OM are estimates and not actual observed data. Hence, the value might not lie within the sampling timepoints provided in the timeframe. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Cmax of N-Desmethyl Bedaquiline | N-Desmethyl Bedaquiline is a metabolite of BDQ. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Cmax,ss of N-Desmethyl Bedaquiline | N-Desmethyl Bedaquiline is a metabolite of BDQ. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number analyzed is the number of participants with data available for analysis. | Posted | | Mean | Standard Deviation | ng/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Tmax of N-Desmethyl Bedaquiline | N-Desmethyl Bedaquiline is a metabolite of BDQ. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | | Median | Full Range | hours | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours (±15 minutes) postdose on Day 1; Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: AUC0-24 for N-Desmethyl Bedaquiline | N-Desmethyl Bedaquiline is a metabolite of BDQ. | PK Analysis Set included all participants who received at least one dose of IMP and had 1 quantifiable drug concentration. Overall number of participants analyzed is the number of participants available for analysis. | Posted | | Mean | Standard Deviation | ng*h/mL | | Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours postdose on Day 1; Predose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Number of Participants With TEAEs on Administration of OPC-167832 in Combination With Delamanid and/or Bedaquiline | An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were all adverse events which started after the start of randomized study drug treatment or if the event was continuous from baseline and was serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study therapy. | Safety Analysis Set included participants who were randomized and received any dose of IMP. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Number of Participants With Clinically Significant Vital Sign Changes on Administration of OPC-167832 in Combination With Delamanid and/or Bedaquiline | | Safety Analysis Set included participants who were randomized and received any dose of IMP. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Secondary | Stage 2: Number of Participants With Clinically Significant Changes in ECG Evaluations on Administration of OPC-167832 in Combination With Delamanid and/or Bedaquiline | | Safety Analysis Set included participants who were randomized and received any dose of IMP. Overall number of participants analyzed is the number of participants available for analysis. | Posted | | Count of Participants | | Participants | | From first dose of study drug to end of follow up period (up to 34 days) | | | | ID | Title | Description |
|---|
| OG000 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg, orally, QD from Day 1 through Day 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG001 | Stage 2: 30 mg OPC-167832 + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with BDQ, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, QD, orally from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. | | OG002 | Stage 2: 30 mg OPC-167832 + 300 mg Delamanid + 400 mg BDQ | Participants received OPC-167832, 30 mg, in combination with delamanid, 300 mg and BDQ, 400 mg, orally, QD, from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. BDQ was then administered at a dose of 400 mg, orally, QD from Days 3 to 14. After Day 14, participants received RHEZ according to the local standard of care regimen up to Day 20. |
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| Other Pre-specified | Correlation of QT Interval and Plasma Concentrations of OPC-167832 and/or Delamanid and/or Bedaquiline | | | Not Posted | | | | | | Day 1 and Day 14 | | Participants | | | | |