| Primary | Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole | T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | Pharmacokinetic (PK) analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Picogram per milliliter (pg/mL) | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0002092.00± 50
- OG0012936.82± 56
|
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| | 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 |
|---|
| Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA) | | | | | Geometric LS Mean Ratio | 139.92 | | | 2-Sided | 90 | 113.26 | 172.87 | | | | | Equivalence | Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259. |
|
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole | T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Hour*picogram per milliliter (hr*pg/mL) | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Primary | Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole | T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "Overall number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Primary | Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin | T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | pg/mL | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin | T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin | T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Secondary | Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole | T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Median | Full Range | Hours | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Secondary | Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole | Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hours | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Secondary | Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole | Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Secondary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole | Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T1= Time frame for "Talazoparib 0.5 mg Alone" and T2= time frame for "Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
| |
| Secondary | Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin | T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. | Posted | | Median | Full Range | Hours | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Secondary | Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin | Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hours | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Secondary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin | Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
| |
| Secondary | Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin | Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T3= Time frame for "Talazoparib 1.0 mg Alone" and T4= time frame for "Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD". | PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25 | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 1.0 mg Alone | Participant received a single oral dose of talazoparib 1.0 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD | Participants received a single oral dose of talazoparib 1.0 mg on Day 25 and oral dose of rifampin 600 mg QD from Day 25 onwards to Day 38 in Period 2. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A TEAE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who received at least 1 dose of talazoparib. Here, 1 participant received 2 doses of rifampin and the SAE anastomotic stenosis took place in the "rifampin" period. Originally, this SAE was attributed to the "talazoparib only" period under the assumption that the participant did not receive any dose of rifampin. This SAE was shifted from the "talazoparib only" period to the "rifampin" period. | Posted | | Count of Participants | | Participants | | Baseline up to end of study (up to 61 days) | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Itraconazole 100 mg BID Alone |
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| Secondary | Number of Participants With Clinical Significance Abnormalities in Laboratory Parameters | Chemistry:(sodium135-146,potassium3.5-5.5,chloride95-109,glucose3.3-5.5,urea2.8-7.2,calcium2.2-2.65,phosphate0.8-1.45,triglyceride0.4-1.7,cholesterol2.6-5.2)millimoles/L, (bilirubin[direct0-3,total2-21],creatinine53- 110)micromole/L, (albumin35-52,protein65-83)g/L,(alkaline phosphatase30-120, aspartate amino[A]transferase[T]4-46, alanine AT4-49, lactic acid dehydrogenase200-460, gammaglutamylT7-50,creatinine kinase24-170)U/L. Hematology: hemoglobin(Hb)120-177, hematocrit0.35-0.49L/L, RBC4-5.9T/L, (platelet150- 400,WBC4-10,basophil<0.10,eosinophil<0.40, neutrophil1.50-7.00,monocyte<1.20,lymphocyte1.0 -3.70)G/L. Urine:(glucose,protein,ketone,Hb:negative/positive), specific gravity1.010-1.030g/cm^3, pH4.8-7.8, pale yellow-deep amber, microscopy[WBC0-5,leukocyte0-5,Hb0-3,cast0-1,bacteria0-500,epithelial0-6])Pcs/area. Coagulation:(activated partial thromboplastine time25-43,prothrombin time13.7-15.6) seconds,international normalized ratio0.89-1.1. Investigator judged clinical significance. | Safety analysis set included all participants who received at least 1 dose of talazoparib. | Posted | | Count of Participants | | Participants | | Baseline up to end of study (up to 61 days) | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Itraconazole 100 mg BID Alone | |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Vital Signs | Vital sign abnormalities: a) systolic blood pressure (SBP): 1) minimum less than (<) 90 millimeter of mercury (mmHg), 2) change from baseline maximum decrease greater than equal to (>=) 30 mmHg, 3) change from baseline maximum increase >=30 mmHg; b) diastolic blood pressure (DBP): 1) minimum <50 mmHg, 2) change from baseline maximum decrease >=20 mmHg, 3) change from baseline maximum increase >=20 mmHg; c) supine pulse rate: 1) minimum <40 beats per minute (bpm), 2) maximum >120 bpm; d) standing pulse rate: 1) minimum <40 bpm and 2) maximum >140 bpm. Clinical significance of vital signs abnormalities was judged by investigator. | Safety analysis set included all participants who received at least 1 dose of talazoparib. | Posted | | Count of Participants | | Participants | | Baseline up to end of study (up to 61 days) | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Itraconazole 100 mg BID Alone | Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2. | | OG002 |
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| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | ECG abnormalities: a) QT Interval: new absolute values greater than (>) 450, >480, >500 milliseconds (msec), increase from baseline >30 and >60 msec, b) QT interval using Fridericia's correction (QTcF) Interval: new absolute values >450, >480, >500 msec, increase from baseline >30 and > 60 msec, c) Heart rate: increase from baseline >25 percentage (%) and to a value >100 bpm, decrease from baseline >25% and to a value <50 bpm, d) PR Interval: increase from baseline > 25% and to a value >200 msec, e) QRS duration: increase from baseline > 25% and to a value >100 msec. Clinical significance of ECG abnormalities was judged by investigator. | Safety analysis set included all participants who received at least 1 dose of talazoparib. | Posted | | Count of Participants | | Participants | | Baseline up to end of study (up to 61 days) | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Itraconazole 100 mg BID Alone | Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2. | | OG002 |
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| Secondary | Number of Participants With Clinically Significant Physical Examination Findings | Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin / subcutaneous tissue, thorax / lungs, abdomen including spleen size, breasts (female only) and respiratory. Clinical significance of physical examination was judged by investigator. | Safety analysis set included all participants who received at least 1 dose of talazoparib. | Posted | | Count of Participants | | Participants | | Baseline up to end of study (up to 61 days) | | | | ID | Title | Description |
|---|
| OG000 | Talazoparib 0.5 mg Alone | Participant received a single oral dose of talazoparib 0.5 mg on Day 1 followed by washout of 14 days in Period 1. | | OG001 | Itraconazole 100 mg BID Alone | Participants those who had received single oral dose of talazoparib 0.5 mg on Day 1 in Period 1, received oral dose of itraconazole 200 mg (100 mg BID) from Day 16 to Day 22 in Period 2. | | OG002 | Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID | Participants received a single oral dose of talazoparib 0.5 mg on Day 23 and oral dose of itraconazole 200 mg (100 mg BID) from Day 23 onwards to Day 36 in Period 2. |
|