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Partially-Blinded, Placebo-Controlled, Randomized, Single Ascending Dose (SAD) with a Food Effect Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBI-223 in Healthy Adults.
This study was a partially-blinded, placebo-controlled, randomized SAD study conducted at one study center. The primary objective of the study was to evaluate the safety and tolerability of single doses of TBI-223 oral suspension, TBI-223 oral enteric capsules, and TBI-223 tablet formulations in healthy adult subjects. The secondary objectives of the study were to determine the PK of TBI-223 and its metabolite M2 after single doses of TBI-223 oral suspension, TBI-223 oral enteric capsules, and TBI-223 tablet formulations in healthy adult subjects, and to compare the rate and extent of absorption of a single dose of TBI-223 oral suspension and TBI-223 tablet formulations when administered in healthy adult subjects either after a high-calorie, high-fat meal or in the fasting state.
Safety was assessed throughout the study for all subjects. Safety assessments included physical examinations, vital signs, serial ECGs, cardiac monitoring, adverse events (AEs), and clinical laboratory tests (including hematology, serum chemistry, coagulation, and urinalysis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI-223 50 mg | Active Comparator | Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions |
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| TBI-223 100 mg | Active Comparator | Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions |
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| TBI-223 300 mg | Active Comparator | Cohort 3a, Period 1 - gave a single dose of TBI-223 300 mg oral suspension dosed under fasted conditions. Cohort 3b, Period 2 - participants in cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg enteric capsule dosed under fasted conditions |
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| TBI-223 600 mg | Active Comparator | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions |
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| TBI-223 1200 mg | Active Comparator | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions. Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg dosed under fed conditions |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBI-223 oral suspension | Drug | TBI-223 oral suspension, orally administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | A treatment-related adverse event (AE) is defined for this study as any AE classified as possibly, probably or certainly related to the study drug. Adverse events (AEs) for participants who received at least one dose of study treatment were collected from the signing of informed consent till the end of study visit. An Investigator reviewed each AE collected and assessed its relationship to drug treatment based on all available information at the time of the completion of the study. | Day 1 - Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time- Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) | AUC0-inf will be calculated from plasma concentrations of TBI-223 AND M2 and calculated as AUC0-inf = AUC0-t + Clast/λz, where λz is the apparent terminal elimination rate constant calculated by linear regression of the terminal linear portion of the log concentration versus time curve | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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Key Inclusion Criteria:
All volunteers must satisfy the following criteria to be considered for study participation:
Key Exclusion Criteria:
History or presence of clinically significant cardiovascular (heart murmur), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
Any presence of musculoskeletal toxicity (severe tenderness with marked impairment of activity, or frank necrosis).
Has a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV at screening.
QTcF interval >450 msec for males or >470 msec for females at screening, Day -1, or Day 1 (predose), or history of prolonged QT syndrome. For the triplicate 12-lead ECGs taken at screening and on Day -1, the average QTcF interval of the three 12-lead ECG recordings were used to determine qualification.
Family history of long-QT syndrome or sudden death without a preceding diagnosis of a condition that was causative of sudden death (such as known coronary artery disease, congestive heart failure, or terminal cancer).
History of any of the following:
Lactose intolerant.
History of sensitivity or contraindication to use of linezolid, tedizolid, or any study investigational products
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Nedelman | Global Alliance for TB Drug Development | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials (WCT) | San Antonio | Texas | 78217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40067046 | Derived | Lombardi A, Pappas F, Bruinenberg P, Nedelman J, Taneja R, Hickman D, Beumont M, Sun E. Pharmacokinetics, tolerability, and safety of TBI-223, a novel oxazolidinone, in healthy participants. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0154224. doi: 10.1128/aac.01542-24. Epub 2025 Mar 11. |
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Cohort 3b, period 2, was added in protocol version 3.0. Some participants chose to return for period 2 and new participants were enrolled for period 2 of cohort 3b.
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| ID | Title | Description |
|---|---|---|
| FG000 | TBI-223 50 mg | Cohort 1, single dose of TBI-223 50 mg oral suspension dosed under fasted conditions. |
| FG001 | TBI-223 100 mg | Cohort 2, single dose of TBI-223 100 mg oral suspension dosed under fasted conditions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 21, 2020 | Dec 7, 2023 |
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This study is partially blinded. The repeat cohort (3b) using a different dosage formulation in Part 1 and subjects in Part 2 will be non-randomized and unblinded.
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| TBI-223 2000 mg | Active Comparator | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions |
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| TBI-223 2600 mg | Active Comparator | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions |
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| TBI-223 placebo | Placebo Comparator | Period 1 Single dose matching placebo for TBI-223 under fasted conditions for cohorts 1 to 7 Period 2 Placebo participants in cohort 5 were invited to return after a washout period and were administered a single dose matching placebo for TBI-223 1200mg under fed conditions |
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| TBI-223 3x600 mg SR-1 tablet | Active Comparator | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions |
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| TBI-223 3x600 mg SR-2 tablet | Active Comparator | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions |
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| TBI-223 2x900 mg SR-3 tablet | Active Comparator | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions |
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| TBI-223 2x1000 mg IR tablet | Active Comparator | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions Cohort 9 - Participants from cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions |
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| TBI-223 enteric capsule | Drug | TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
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| TBI-223 SR Tablet Prototype 1 | Drug | TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
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| TBI-223 SR Tablet Prototype 2 | Drug | TBI-223 600 mg SR tablet Prototype 2, orally administered. |
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| TBI-223 SR Tablet Prototype 3 | Drug | TBI-223 900 mg SR tablet Prototype 3, orally administered. |
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| TBI-223 IR Tablet | Drug | TBI-223 1000 mg immediate release (IR) tablet, orally administered |
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| Placebo suspension | Drug | Placebo for TBI-223 oral Suspension; orally administered. |
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| AUC0-t | AUC0-t will be calculated from plasma concentrations of TBI-223. Area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration (Clast), as calculated by the linear trapezoidal rule. | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Maximum Plasma Concentration, Determined Directly From Individual Concentration-time- Data (Cmax) | Cmax will be calculated from plasma concentrations of TBI-223. Cmax is calculated as the maximum plasma concentration, determined directly from individual concentration-time- data | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Time of the Maximum Plasma Concentrations (Tmax) | Tmax will be calculated from plasma concentrations of TBI-223. | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| The Observed Terminal Elimination Half-life (t1/2) | T1/2 will be calculated from plasma concentrations of TBI-223 and calculated as T½ = ln(2)/λz | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 300 mg TBI-223 in Capsule to Oral Suspension Formulations | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 300 mg Dose of TBI-223 Capsule Formulation (Cohort 3 Repeat; Part 1; Test) and a Single 300 mg Dose of TBI-223 Oral Suspension (Cohort 3; Part 1; Reference). | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1200 mg Oral Suspension Under Fasted to Fed Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 1200 mg Dose of TBI-223 Oral Suspension under Fed (Test) and Fasted (Reference) Conditions (Part 1; Cohort 5) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 2000 mg of Immediate Release (IR) Tablets Under Fed to Fasted Conditions. | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as IR tablets, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 9; Test) and IR tablets, 2000 mg (2 x1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of TBI-223 1800 mg Sustained Release (SR) Tablets Under Fed Conditions to 2000 mg IR Tablets Under Fasted Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as SR (Prototypes 1, 2, and 3) under Fed Conditions (Cohort 8; Test) and IR, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1800 mg SR Tablets (Prototypes 1, 2, 3,) to 2000 mg IR Tablets Under Fed Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as TBI-223 after 1800 mg SR tablets (Prototypes 1, 2, 3,) under Fed Conditions (Cohort 8; Test) and 2000 mg IR tablets (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 8; Reference) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
| FG002 | TBI-223 300 mg | Cohort 3a, Period 1 - gave a single dose of TBI-223 300 mg oral suspension dosed under fasted conditions. Cohort 3b, Period 2 - participants in cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions |
| FG003 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg oral suspension dosed under fasted conditions. |
| FG004 | TBI-223 1200 mg | Cohort 5, Period 1, single dose of TBI-223 1200 mg oral suspension dosed under fasted conditions. Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg oral suspension dosed under fed conditions. |
| FG005 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg oral suspension dosed under fasted conditions. |
| FG006 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg oral suspension dosed under fasted conditions. |
| FG007 | TBI-223 Placebo | Period 1 Single dose matching placebo for TBI-223 oral suspension under fasted conditions for cohorts 1 to 7 Period 2 Placebo participants in cohort 5 were invited to return after a washout period and were administered a single dose matching placebo for TBI-223 1200mg oral suspension under fed conditions |
| FG008 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions. |
| FG009 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions. |
| FG010 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions. |
| FG011 | TBI-223 2x1000 mg IR Tablet | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions Cohort 9 Participants from Cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions |
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| NOT COMPLETED |
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| Washout Period |
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| Period 2 |
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All participants to whom a treatment was randomly assigned. Note that participants in cohort 3 were added for period 2 to replace participants who declined to return after period 1 and the baseline description contains all participants for cohort 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | TBI-223 Placebo | Part 1 Single dose matching placebo for TBI-223 under fasted conditions Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered |
| BG001 | TBI-223 50 mg | Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG002 | TBI-223 100 mg | Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG003 | TBI-223 300 mg | Cohort 3a, Period 1 - single dose of TBI-223 300 mg oral suspension dosed under fasted conditions Cohort 3b, Period 2 - participants in Cohort 3a were invited after a washout period to return for an additional single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions |
| BG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG005 | TBI-223 1200 mg | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions Cohort 5, Period 2, participants were invited to return after a washout period to continue in period 2 and receive a single dose of TBI-223 1200 mg oral suspension dosed under fed conditions. TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG006 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG007 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| BG008 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| BG009 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| BG010 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 -Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| BG011 | TBI-223 2x1000 mg IR Tablet | Cohort 8, arm 4 -Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions Cohort 9 - Participants from Cohort 8 arm 4 were invited to return and were administered a single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| BG012 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-related Adverse Events | A treatment-related adverse event (AE) is defined for this study as any AE classified as possibly, probably or certainly related to the study drug. Adverse events (AEs) for participants who received at least one dose of study treatment were collected from the signing of informed consent till the end of study visit. An Investigator reviewed each AE collected and assessed its relationship to drug treatment based on all available information at the time of the completion of the study. | All participants who received at least one dose of study treatment. Note: participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study. | Posted | Count of Participants | Participants | Day 1 - Day 11 |
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| Secondary | Area Under the Plasma Concentration-time- Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) | AUC0-inf will be calculated from plasma concentrations of TBI-223 AND M2 and calculated as AUC0-inf = AUC0-t + Clast/λz, where λz is the apparent terminal elimination rate constant calculated by linear regression of the terminal linear portion of the log concentration versus time curve | Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. AUCs for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose. | Posted | Mean | Standard Deviation | h*ng/mL | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | AUC0-t | AUC0-t will be calculated from plasma concentrations of TBI-223. Area under the plasma concentration-time curve from time-zero to the time of the last quantifiable concentration (Clast), as calculated by the linear trapezoidal rule. | Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. AUCs for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose. Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study. | Posted | Mean | Standard Deviation | h*ng/mL | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Maximum Plasma Concentration, Determined Directly From Individual Concentration-time- Data (Cmax) | Cmax will be calculated from plasma concentrations of TBI-223. Cmax is calculated as the maximum plasma concentration, determined directly from individual concentration-time- data | Participants are divided into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. Some participants are in more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. Cmax for SR-1, SR-2, and SR-3 were normalized to the 2000 mg dose. | Posted | Mean | Standard Deviation | ng/mL | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Time of the Maximum Plasma Concentrations (Tmax) | Tmax will be calculated from plasma concentrations of TBI-223. | Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. | Posted | Median | Full Range | hours | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | The Observed Terminal Elimination Half-life (t1/2) | T1/2 will be calculated from plasma concentrations of TBI-223 and calculated as T½ = ln(2)/λz | Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study. Two subjects from Cohort 7 experienced emesis at 1.17 h and 1.37 h, respectively, after dosing. Data for these subjects were excluded from analyses of PK outcome measures. | Posted | Mean | Standard Deviation | hours | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 300 mg TBI-223 in Capsule to Oral Suspension Formulations | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 300 mg Dose of TBI-223 Capsule Formulation (Cohort 3 Repeat; Part 1; Test) and a Single 300 mg Dose of TBI-223 Oral Suspension (Cohort 3; Part 1; Reference). | Participants enrolled in cohort 3a and cohort 3b who received TBI-223. Participants from cohort 3a were invited to participate in cohort 3b and additional participants were enrolled in 3b to replace those who elected not to participate. | Posted | Geometric Mean | 90% Confidence Interval | ratio (%) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1200 mg Oral Suspension Under Fasted to Fed Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as a Single 1200 mg Dose of TBI-223 Oral Suspension under Fed (Test) and Fasted (Reference) Conditions (Part 1; Cohort 5) | All participants who enrolled in cohort 5 and received TBI-223. Participants in period 1 were invited to participate in period 2. | Posted | Geometric Mean | 90% Confidence Interval | ratio (%) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 2000 mg of Immediate Release (IR) Tablets Under Fed to Fasted Conditions. | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as IR tablets, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 9; Test) and IR tablets, 2000 mg (2 x1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference) | All participants who enrolled were enrolled in cohort 8, arm 4 and were also enrolled in cohort 9. | Posted | Geometric Mean | 90% Confidence Interval | ratio (%) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of TBI-223 1800 mg Sustained Release (SR) Tablets Under Fed Conditions to 2000 mg IR Tablets Under Fasted Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as SR (Prototypes 1, 2, and 3) under Fed Conditions (Cohort 8; Test) and IR, 2000 mg (2 x 1000 mg TBI-223 tablets) under Fasted Conditions (Cohort 8; Reference) | SR-1, SR-2, and SR-3 parameters were dose-normalized to 2000 mg prior to analysis | Posted | Geometric Mean | 90% Confidence Interval | ratio (%) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
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| Secondary | Geometric Mean Ratio and 90% Confidence Interval (CI) of Cmax, AUC0-t and AUC 0-inf of 1800 mg SR Tablets (Prototypes 1, 2, 3,) to 2000 mg IR Tablets Under Fed Conditions | Geometric mean ratio of TBI-223 area under the (plasma concentration vs. time) curve and Cmax when administered as TBI-223 after 1800 mg SR tablets (Prototypes 1, 2, 3,) under Fed Conditions (Cohort 8; Test) and 2000 mg IR tablets (2 x 1000 mg TBI-223 tablets) under Fed Conditions (Cohort 8; Reference) | SR-1, SR-2, and SR-3 parameters were dose-normalized to 2000 mg prior to analysis | Posted | Geometric Mean | 90% Confidence Interval | ratio (%) | predose (0 hour) and at 0.5, 1.0, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 72 hours after administration of the investigational product |
|
Day 1 - Day 11
Subjects were instructed to inform the research personnel of any AEs that occurred at any time during the study. Subjects were monitored for AEs from the first dose through the end-of-study visit. Reported or observed AEs were documented and followed to resolution. Participants are divided here into analysis groups based on the drug and formulation taken and fed vs fasted status at dosing. This puts some participants into more than one analysis group based on the design of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TBI-223 Placebo | Part 1 Single dose matching placebo for TBI-223 Placebo suspension: Placebo for TBI-223 oral Suspension; orally administered. | 0 | 14 | 0 | 14 | 4 | 14 |
| EG001 | TBI-223 50 mg | Cohort 1, single dose of TBI-223 50 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | TBI-223 100 mg | Cohort 2, single dose of TBI-223 100 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | TBI-223 300 mg Oral Suspension | Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG007 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG008 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG009 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG010 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG011 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 -Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG012 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 -Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG013 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 -Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered | 0 | 6 | 0 | 6 | 3 | 6 |
| EG014 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered | 0 | 6 | 0 | 6 | 2 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Energy Increased | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel puncture site inflammation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel puncture site reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Majda Benhayoun | TB Alliance | 347-601-8225 | majda.benhayoun@tballiance.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 28, 2020 | Dec 11, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | TBI-223 300 mg Oral Suspension | Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG003 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
| OG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG005 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG006 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG007 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG008 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG009 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| OG010 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| OG011 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| OG012 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| OG013 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
|
|
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG003 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
| OG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG005 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG006 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG007 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG008 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG009 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| OG010 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| OG011 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| OG012 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| OG013 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
|
|
Cohort 3a, single dose of TBI-223 300 mg oral suspension dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG003 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
| OG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG005 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG006 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG007 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG008 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG009 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| OG010 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| OG011 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| OG012 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| OG013 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
|
|
| OG003 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
| OG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG005 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG006 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG007 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG008 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG009 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| OG010 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| OG011 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| OG012 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| OG013 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
|
|
| OG003 | TBI-223 300 mg Oral Enteric Capsules | Cohort 3b, single dose of TBI-223 300 mg as powder in enteric capsules dosed under fasted conditions TBI-223 capsule: TBI-223 enteric capsules filled with 150 mg of TBI-223 powder, orally administered. |
| OG004 | TBI-223 600 mg | Cohort 4, single dose of TBI-223 600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG005 | TBI-223 1200 mg Fasted | Cohort 5, Period 1, single dose of TBI-223 1200 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG006 | TBI-223 1200 mg Fed | Cohort 5, Period 2, single dose of TBI-223 1200 mg dosed under fed conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG007 | TBI-223 2000 mg | Cohort 6, single dose of TBI-223 2000 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG008 | TBI-223 2600 mg | Cohort 7, single dose of TBI-223 2600 mg dosed under fasted conditions TBI-223 oral suspension: TBI-223 oral suspension, orally administered. |
| OG009 | TBI-223 3x600 mg SR-1 Tablet | Cohort 8, arm 1 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 1 under fed conditions TBI-223 SR Tablet Prototype 1: TBI-223 600 mg sustained-release (SR) tablet Prototype 1, orally administered. |
| OG010 | TBI-223 3x600 mg SR-2 Tablet | Cohort 8, arm 2 - Single dose TBI-223 of 1800 mg (3 x 600 mg) sustained release (SR) tablet formulation 2 under fed conditions TBI-223 SR Tablet Prototype 2: TBI-223 600 mg SR tablet Prototype 2, orally administered. |
| OG011 | TBI-223 2x900 mg SR-3 Tablet | Cohort 8, arm 3 - Single dose TBI-223 of 1800 mg (2 x 900 mg) sustained release (SR) tablet formulation 3 under fed conditions TBI-223 SR Tablet Prototype 3: TBI-223 900 mg SR tablet Prototype 3, orally administered. |
| OG012 | TBI-223 2x1000 mg IR Tablet Fasted | Cohort 8, arm 4 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fasted conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
| OG013 | TBI-223 2x1000 mg IR Tablet Fed | Cohort 9 - Single dose TBI-223 of 2000 mg (2 x 1000 mg) immediate release (IR) tablet under fed conditions TBI-223 IR Tablet: TBI-223 1000 mg immediate release (IR) tablet, orally administered |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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