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This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects.
This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same 4-sequence, 4- period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: Pretomanid after meal | Experimental | Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 1 will receive a meal before dosing. |
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| Panel 2: Pretomanid after fast | Experimental | Each participant will receive four single-dose treatments with a 7-day washout period between each dose. Panel 2 will fast before dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pretomanid | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability - Cmax | Relative bioavailability will be determined separately for each panel using Cmax | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
| Relative Bioavailability - AUC 0-t | Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h*ng/mL) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
| Relative Bioavailability - AUC 0-inf | Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Food Effect - Ratio of Cmax Fed Vs Fasted | Food effect on bioavailability will be determined across panels using Cmax. Reported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Lombardi, MD | TB Alliance | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials Early Phase Services, LLC | San Antonio | Texas | 78217 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36180816 | Derived | Zou Y, Nedelman J, Lombardi A, Pappas F, Karlsson MO, Svensson EM. Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling. Clin Pharmacokinet. 2022 Nov;61(11):1585-1593. doi: 10.1007/s40262-022-01163-w. Epub 2022 Sep 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Panel 1: Pretomanid After Meal | Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 6, 2019 | Jul 26, 2023 |
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Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.
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| Food Effect - Ratio of AUC 0-t Fed Vs Fasted | Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect. | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
| Food Effect - Ratio of AUC 0-inf Fed Vs Fasted | Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
| Adverse Events - Overall Incidence | All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including | throughout the study, approximately 33 days |
| FG001 | Panel 2: Pretomanid After Fast | Each participant will receive four single-dose treatments. Panel 2 will fast before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Panel 1: Pretomanid After Meal | Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing. |
| BG001 | Panel 2: Pretomanid After Fast | Each participant will receive four single-dose treatments. Panel 2 will fast before dosing. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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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| Height at Screening | Mean | Standard Deviation | centimeter |
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| Weight at Screening | Mean | Standard Deviation | kilogram |
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| BMI at Screening | Mean | Standard Deviation | kilogram per meter squared |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Bioavailability - Cmax | Relative bioavailability will be determined separately for each panel using Cmax | Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles | Posted | Mean | Standard Deviation | ng/mL | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Primary | Relative Bioavailability - AUC 0-t | Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h*ng/mL) | Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles | Posted | Mean | Standard Deviation | h*ng/mL | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Primary | Relative Bioavailability - AUC 0-inf | Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time) | Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles | Posted | Mean | Standard Deviation | h*ng/mL | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Secondary | Food Effect - Ratio of Cmax Fed Vs Fasted | Food effect on bioavailability will be determined across panels using Cmax. Reported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL) | Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles | Posted | Number | 90% Confidence Interval | Ratio (%) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Secondary | Food Effect - Ratio of AUC 0-t Fed Vs Fasted | Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect. | Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles | Posted | Number | 90% Confidence Interval | Ratio (%) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Secondary | Food Effect - Ratio of AUC 0-inf Fed Vs Fasted | Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect | Posted | Number | 90% Confidence Interval | Ratio (%) | intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose |
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| Secondary | Adverse Events - Overall Incidence | All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including | All participants randomized | Posted | Count of Participants | Participants | throughout the study, approximately 33 days |
|
Day 1 to Day 33
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel 1: Treatment A | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. | 0 | 24 | 0 | 24 | 5 | 24 |
| EG001 | Panel 1: Treatment B | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. | 0 | 24 | 0 | 24 | 9 | 24 |
| EG002 | Panel 1: Treatment C | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. | 0 | 24 | 0 | 24 | 2 | 24 |
| EG003 | Panel 1: Treatment D | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. | 0 | 24 | 0 | 24 | 6 | 24 |
| EG004 | Panel 2:Treatment A | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered | 0 | 24 | 0 | 24 | 3 | 24 |
| EG005 | Panel 2: Treatment B | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered | 0 | 24 | 0 | 24 | 3 | 24 |
| EG006 | Panel 2: Treatment C | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered | 0 | 24 | 0 | 24 | 1 | 24 |
| EG007 | Panel 2: Treatment D | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered | 0 | 24 | 0 | 24 | 4 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 23.0 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA version 23.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 23.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 23.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA version 23.0 | Systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA version 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 23.0 | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA version 23.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA version 23.0 | Systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA version 23.0 | Systematic Assessment |
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| Blood Bilirubin Increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 23.0 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA version 23.0 | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA version 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Egizi | TB Alliance | 917-696-4984 | erica.egizi@tballiance.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2020 | Jul 26, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| D054908 | Extensively Drug-Resistant Tuberculosis |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C410767 | pretomanid |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Treatment B |
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| Treatment C |
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| Treatment D |
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| ANOVA |
| 0.3001 |
| Geometric mean ratio (%) |
| 92.99 |
| 2-Sided |
| 90 |
| 82.65 |
| 104.62 |
| Equivalence |
Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. |
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| OG002 |
| Treatment C Fed and Fasted |
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing. Treatment C (test) = single 50-mg dispersible tablet, orally administered. |
| OG003 | Treatment D Fed and Fasted | Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing. Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
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| OG002 | Treatment C Fed and Fasted | Each participant will receive four single-dose treatments in both fed and fasted conditions Pretomanid: 1) Treatment C (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. |
| OG003 | Treatment D Fed and Fasted | Each participant will receive four single-dose treatments in both fed and fasted conditions Pretomanid: 1) Treatment D(reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. |
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| OG003 | Treatment D Fed and Fasted | Each participant will receive four single-dose treatments in both fed and fasted conditions Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
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| OG002 | Panel 1: Treatment C | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
| OG003 | Panel 1: Treatment D | Each participant received four single-dose treatments. Panel 1 received a meal before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered. |
| OG004 | Panel 2:Treatment A | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered |
| OG005 | Panel 2: Treatment B | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered |
| OG006 | Panel 2: Treatment C | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered |
| OG007 | Panel 2: Treatment D | Each participant received four single-dose treatments. Panel 2 fasted before dosing. Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered. 2) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered. 3) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered |
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