Trial Outcomes & Findings for Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function (NCT NCT03896750)
NCT ID: NCT03896750
Last Updated: 2025-11-25
Results Overview
The mean fold change of AUC(0-last) Area under the concentration time-curve to the last concentration above the lower limit of quantitation at specified pre-dose and post-dose time points was calculated by noncompartmental analysis using the linear up log down method. The mean fold change of each enrolled renal impairment arm as compared to the Healthy Matched Control arm was calculated by a linear regression model controlling for site.
COMPLETED
PHASE1
12 participants
Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.
2025-11-25
Participant Flow
The study population was represented by participants of varying degrees of renal disease, recruited from the community at large. Participants were between 18 and 85 years, inclusive at the time of enrollment. Enrollment occurred from 17APR2024 to 05AUG2024.
Participant milestones
| Measure |
Part A Group 1A - Healthy Matched Controls
Healthy participants with normal renal function: Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR \> / = 90 mL/min) matched to Group 2 by race, gender, age (+/- 10 years, but between 18 to 85 years of age) and body mass index (BMI) (18 to 40 kg/m\^2) will receive a single oral dose of 200 mg pretomanid
PA-824: PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
|
Part A Group 2 - ESRD Not on Dialysis
Participants with End Stage Renal Disease (ESRD) not on dialysis: Stage 5, Modification of Diet in Renal Disease (MDRD) with estimated Glomerular Filtration Rate (eGFR \< 15 mL/min) matched to Group 1A will receive a single oral dose of 200 mg pretomanid
PA-824: PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
|
Part A Group 2 - Severe Renal Impairment
Participants with severe renal impairment: Stage 4, Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR 15-29 mL/min) matched to Group 1A will receive a single oral dose of 200 mg pretomanid
PA-824: PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
|
Part B Group 3 - Mild Renal Impairment
Participants with mild renal impairment: Stage 2, Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR 60-89 mL/min) matched to Group 1B will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed
PA-824: PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
|
Part B Group 4 - Moderate Renal Impairment
Participants with moderate renal impairment: Stage 3, Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR = 30-59 mL/min) matched to Group 1C will receive a single oral dose of 200 mg pretomanid after the PK and safety of subjects enrolled in Part A have been reviewed
PA-824: PA-824, a nitroimidazooxazine, used in prior studies of pretomanid is a novel TB treatment that is being investigated for use with other TB drugs to shorten and/or simplify regimens to treat either drug susceptible or resistant disease. After fasting for a minimum of 8 hours, subjects will receive one dose of 200 mg of pretomanid orally under direct supervision with 240 mL of water and a mouth check will be done.
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|---|---|---|---|---|---|
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Overall Study
STARTED
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6
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1
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5
|
0
|
0
|
|
Overall Study
COMPLETED
|
6
|
1
|
5
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
Baseline characteristics by cohort
| Measure |
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.3 years
STANDARD_DEVIATION 12.8 • n=45 Participants
|
40.0 years
n=12929 Participants
|
62.0 years
STANDARD_DEVIATION 10.0 • n=6349 Participants
|
56.3 years
STANDARD_DEVIATION 12.3 • n=4548 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
6 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
6 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
7 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
5 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
10 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=45 Participants
|
1 participants
n=12929 Participants
|
5 participants
n=6349 Participants
|
12 participants
n=4548 Participants
|
|
BMI
|
32.17 kg/m^2
STANDARD_DEVIATION 2.84 • n=45 Participants
|
40.0 kg/m^2
n=12929 Participants
|
36.02 kg/m^2
STANDARD_DEVIATION 3.42 • n=6349 Participants
|
34.43 kg/m^2
STANDARD_DEVIATION 3.83 • n=4548 Participants
|
|
Height
|
163.55 cm
STANDARD_DEVIATION 8.85 • n=45 Participants
|
155.00 cm
n=12929 Participants
|
167.42 cm
STANDARD_DEVIATION 3.61 • n=6349 Participants
|
164.45 cm
STANDARD_DEVIATION 7.27 • n=4548 Participants
|
|
Weight
|
86.62 kg
STANDARD_DEVIATION 15.15 • n=45 Participants
|
96.00 kg
n=12929 Participants
|
101.12 kg
STANDARD_DEVIATION 11.53 • n=6349 Participants
|
93.44 kg
STANDARD_DEVIATION 14.34 • n=4548 Participants
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PRIMARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
The mean fold change of AUC(0-last) Area under the concentration time-curve to the last concentration above the lower limit of quantitation at specified pre-dose and post-dose time points was calculated by noncompartmental analysis using the linear up log down method. The mean fold change of each enrolled renal impairment arm as compared to the Healthy Matched Control arm was calculated by a linear regression model controlling for site.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Fold Change in Pretomanid AUC(0-last) in Participants With Renal Impairment as Compared to Matched Healthy Controls
|
63600 ng*h/mL
|
62660 ng*h/mL
Interval 54280.0 to 71040.0
|
77130 ng*h/mL
Interval 62810.0 to 91460.0
|
PRIMARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
The mean fold change of AUC(0-infinity) was calculated by noncompartmental analysis using the linear up log down method with the area extrapolated to infinity as Clast/Lambda\_z where Clast was the last observed concentration and Lambda\_z is the elimination rate constant. The mean fold change of each enrolled renal impairment arm as compared to the Healthy Matched Control arm was calculated by a linear regression model controlling for site.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Fold Change in Pretomanid AUC(0-infinity) in Participants With Renal Impairment as Compared to Matched Healthy Controls
|
76400 ng*h/mL
|
76740 ng*h/mL
Interval 66610.0 to 86870.0
|
88650 ng*h/mL
Interval 69340.0 to 108000.0
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
AUC(0-infinity) was calculated by noncompartmental analysis using the linear up log down method with the area extrapolated to infinity as Clast/Lambda\_z where Clast was the last observed concentration and Lambda\_z is the elimination rate constant. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Area Under the M19 and M50 Concentration Time-curve Extrapolated to Infinity at Specified Pre-dose and Post-dose Time Points
M19
|
5980 ng*h/mL
|
7458 ng*h/mL
Standard Deviation 4410
|
4013 ng*h/mL
Standard Deviation 2021
|
|
Area Under the M19 and M50 Concentration Time-curve Extrapolated to Infinity at Specified Pre-dose and Post-dose Time Points
M50
|
737.0 ng*h/mL
|
1132 ng*h/mL
Standard Deviation 547.1
|
700.7 ng*h/mL
Standard Deviation 251.3
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
AUC(0-last) Area under the concentration time-curve to the last concentration above the lower limit of quantitation at specified pre-dose and post-dose time points was calculated by noncompartmental analysis using the linear up log down method. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Area Under the M19 and M50 Concentration Time-curve to the Last Concentration Above the Lower Limit of Quantitation at Specified Pre-dose and Post-dose Time Points
M19
|
4150 ng*h/mL
|
4746 ng*h/mL
Standard Deviation 3064
|
3503 ng*h/mL
Standard Deviation 1852
|
|
Area Under the M19 and M50 Concentration Time-curve to the Last Concentration Above the Lower Limit of Quantitation at Specified Pre-dose and Post-dose Time Points
M50
|
631.0 ng*h/mL
|
932.8 ng*h/mL
Standard Deviation 479.7
|
585.0 ng*h/mL
Standard Deviation 202.5
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SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
Maximum M19 and M50 concentrations is the maximum observed drug concentration in blood plasma at specified pre-dose and post-dose timepoints. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Maximum M19 and M50 Concentrations at Specified Pre-dose and Post-dose Time Points
M19
|
81.30 ng/mL
|
73.66 ng/mL
Standard Deviation 48.38
|
82.05 ng/mL
Standard Deviation 33.34
|
|
Maximum M19 and M50 Concentrations at Specified Pre-dose and Post-dose Time Points
M50
|
12.60 ng/mL
|
16.28 ng/mL
Standard Deviation 8.149
|
15.05 ng/mL
Standard Deviation 3.603
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
Apparent terminal half-life of M19 and M50 at specified pre-dose and post-dose timepoints was estimated by ln(2)/Lambda\_z, where Lambda\_z is the elimination rate constant. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Apparent Terminal Elimination Half-life of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M50
|
31.0 Hours
|
35.68 Hours
Standard Deviation 5.97
|
31.12 Hours
Standard Deviation 7.13
|
|
Apparent Terminal Elimination Half-life of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M19
|
48.80 Hours
|
53.68 Hours
Standard Deviation 14.29
|
31.58 Hours
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK urine analysis subset will consist of all participants with sufficient urine PK data available to estimate the urine PK parameters.
Renal clearance (CLr) of M19 and M50 calculated as the amount excreted in urine to time t in urine divided by the plasma AUC from 0 to time t. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Renal Clearance of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M19
|
0.170 L/h
|
0.440 L/h
Standard Deviation 0.567
|
0.222 L/h
Standard Deviation 0.134
|
|
Renal Clearance of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M50
|
0.930 L/h
|
0.634 L/h
Standard Deviation 0.139
|
5.935 L/h
Standard Deviation 3.857
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK urine analysis subset will consist of all participants with sufficient urine PK data available to estimate the urine PK parameters.
Amount of M19 and M50 excreted in Urine \[Ae(0-t)\] is the sum of the amount of M19 and M50 recovered in urine during the collection window. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Amount of M19 and M50 Excreted in Urine at Specified Pre-dose and Post-dose Time Points
M19
|
715.0 ug
|
1637 ug
Standard Deviation 1894
|
678.3 ug
Standard Deviation 314.0
|
|
Amount of M19 and M50 Excreted in Urine at Specified Pre-dose and Post-dose Time Points
M50
|
585.0 ug
|
548.0 ug
Standard Deviation 143.4
|
3302 ug
Standard Deviation 2420
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
Apparent Volume of Distribution at specified pre-dose and post-dose timepoints is the volume that the total amount of administered drug would occupy to provide the same concentration as it currently is in blood plasma divided by the bioavailability. It is calculated by Dose/\[Lambda\_z x AUC(0-infinity)\]. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Apparent Volume of Distribution of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M19
|
2350 L
|
3106 L
Standard Deviation 2543
|
2793 L
Standard Deviation 1414
|
|
Apparent Volume of Distribution of M19 and M50 at Specified Pre-dose and Post-dose Time Points
M50
|
12100 L
|
10540 L
Standard Deviation 4333
|
13570 L
Standard Deviation 3050
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
Time of maximum M19 and M50 concentration (Tmax) at specified pre-dose and post-dose timepoints. M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Time of Maximum M19 and M50 Concentration at Specified Pre-dose and Post-dose Time Points
M19
|
24.00 Hours
|
22.42 Hours
Standard Deviation 15.43
|
10.67 Hours
Standard Deviation 7.45
|
|
Time of Maximum M19 and M50 Concentration at Specified Pre-dose and Post-dose Time Points
M50
|
16.00 Hours
|
13.60 Hours
Standard Deviation 2.19
|
7.50 Hours
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: Day 1 at 1, 2, 4, 5, 6, 8, 12, 16 hours post dose; Day 2 at 24 and 36 hours post dose; Day 3 at 48 hours post dose; Day 4 at 72 hours post dose; and Day 5 at 96 hours post dose.Population: The PK plasma analysis subset consisted of all participants with sufficient plasma PK data available to estimate the plasma PK parameters using noncompartmental methods.
Apparent oral clearance was calculated by noncompartmental analysis using the formula Dose/AUC(0-infinity). M19 and M50 are the two primary representative metabolites of pretomanid.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Apparent Oral Clearance of M19 and M50 From Dose/AUC(0-infinity) at Specified Pre-dose and Post-dose Time Points
M50
|
272.0 L/h
|
200.5 L/h
Standard Deviation 62.07
|
318.8 L/h
Standard Deviation 116.5
|
|
Apparent Oral Clearance of M19 and M50 From Dose/AUC(0-infinity) at Specified Pre-dose and Post-dose Time Points
M19
|
33.40 L/h
|
36.50 L/h
Standard Deviation 24.10
|
59.73 L/h
Standard Deviation 24.27
|
SECONDARY outcome
Timeframe: Day 1 to Day 85Population: The safety analysis population set included all participants who receive any amount of study product.
An Adverse Event (AE) was defined as any unfavorable or unintended medical occurrence temporally associated with the use of a study drug, device, other medical product, or procedure whether or not it is considered related to the product itself.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Number of Participants With and Severity of Adverse Events
Lab finding of Mild or Worse Severity Through Day 12
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With and Severity of Adverse Events
Unsolicited AEs
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With and Severity of Adverse Events
Unsolicited Treatment Emergent AEs
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With and Severity of Adverse Events
Mild Related Unsolicited Treatment Emergent AEs
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With and Severity of Adverse Events
Moderate Related Unsolicited Treatment Emergent AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Alanine Aminotransferase (ALT)
Day 5
|
2.0 U/L
|
2.0 U/L
Standard Deviation 8.2
|
0.0 U/L
Standard Deviation 5.5
|
|
Mean Change From Baseline in Alanine Aminotransferase (ALT)
Day 12
|
1.0 U/L
|
4.0 U/L
Standard Deviation 7.6
|
1.2 U/L
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Aspartate Aminotransferase (AST)
Day 5
|
1.0 U/L
|
0.4 U/L
Standard Deviation 1.5
|
-2.3 U/L
Standard Deviation 4.6
|
|
Mean Change From Baseline in Aspartate Aminotransferase (AST)
Day 12
|
-2.0 U/L
|
0.8 U/L
Standard Deviation 2.5
|
0.5 U/L
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Blood Urea Nitrogen (BUN)
Day 5
|
2.0 mg/dL
|
6.6 mg/dL
Standard Deviation 19.6
|
-1.5 mg/dL
Standard Deviation 4.5
|
|
Mean Change From Baseline in Blood Urea Nitrogen (BUN)
Day 12
|
-9.0 mg/dL
|
3.0 mg/dL
Standard Deviation 23.0
|
-1.2 mg/dL
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Creatinine
Day 5
|
-0.520 mg/dL
|
0.330 mg/dL
Standard Deviation 0.738
|
0.032 mg/dL
Standard Deviation 0.097
|
|
Mean Change From Baseline in Creatinine
Day 12
|
-0.400 mg/dL
|
0.028 mg/dL
Standard Deviation 0.448
|
-0.017 mg/dL
Standard Deviation 0.108
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Hemoglobin (Hgb)
Day 5
|
-0.60 g/dL
|
-0.66 g/dL
Standard Deviation 0.85
|
0.52 g/dL
Standard Deviation 0.83
|
|
Mean Change From Baseline in Hemoglobin (Hgb)
Day 12
|
0.00 g/dL
|
-1.26 g/dL
Standard Deviation 0.65
|
-0.37 g/dL
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Day 5
|
4.0 mL/min/1.73m^2
|
-2.6 mL/min/1.73m^2
Standard Deviation 5.5
|
-6.0 mL/min/1.73m^2
Standard Deviation 19.9
|
|
Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Day 12
|
1.0 mL/min/1.73m^2
|
0.6 mL/min/1.73m^2
Standard Deviation 2.6
|
3.2 mL/min/1.73m^2
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Magnesium
Day 5
|
-0.20 mg/dL
|
-0.10 mg/dL
Standard Deviation 0.22
|
-0.12 mg/dL
Standard Deviation 0.20
|
|
Mean Change From Baseline in Magnesium
Day 12
|
-0.20 mg/dL
|
-0.04 mg/dL
Standard Deviation 0.23
|
0.00 mg/dL
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Serum Potassium
Day 5
|
0.60 mmol/L
|
0.18 mmol/L
Standard Deviation 0.42
|
0.27 mmol/L
Standard Deviation 0.46
|
|
Mean Change From Baseline in Serum Potassium
Day 12
|
0.10 mmol/L
|
0.14 mmol/L
Standard Deviation 0.71
|
0.12 mmol/L
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Day 5 and Day 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change From Baseline in Total Bilirubin
Day 5
|
0.00 mg/dL
|
-0.02 mg/dL
Standard Deviation 0.25
|
0.03 mg/dL
Standard Deviation 0.27
|
|
Mean Change From Baseline in Total Bilirubin
Day 12
|
0.00 mg/dL
|
-0.02 mg/dL
Standard Deviation 0.15
|
0.10 mg/dL
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, and 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change in Oral Temperature From Baseline
Day 1 (12 hours post-dose)
|
-0.90 degrees Fahrenheit
|
0.14 degrees Fahrenheit
Standard Deviation 0.54
|
-0.07 degrees Fahrenheit
Standard Deviation 0.31
|
|
Mean Change in Oral Temperature From Baseline
Day 2 (24 hours post-dose)
|
-0.50 degrees Fahrenheit
|
-0.22 degrees Fahrenheit
Standard Deviation 0.24
|
-0.12 degrees Fahrenheit
Standard Deviation 0.15
|
|
Mean Change in Oral Temperature From Baseline
Day 3 (48 hours post-dose)
|
-0.20 degrees Fahrenheit
|
0.20 degrees Fahrenheit
Standard Deviation 0.53
|
-0.10 degrees Fahrenheit
Standard Deviation 0.26
|
|
Mean Change in Oral Temperature From Baseline
Day 4 (72 hours post-dose)
|
-0.20 degrees Fahrenheit
|
-0.24 degrees Fahrenheit
Standard Deviation 0.34
|
-0.22 degrees Fahrenheit
Standard Deviation 0.31
|
|
Mean Change in Oral Temperature From Baseline
Day 5 (96 hours post-dose)
|
-0.70 degrees Fahrenheit
|
-0.06 degrees Fahrenheit
Standard Deviation 0.21
|
-0.28 degrees Fahrenheit
Standard Deviation 0.42
|
|
Mean Change in Oral Temperature From Baseline
Day 12
|
-1.20 degrees Fahrenheit
|
0.02 degrees Fahrenheit
Standard Deviation 0.16
|
-0.22 degrees Fahrenheit
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, and 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change in Pulse From Baseline
Day 1 (12 hours post-dose)
|
-8.0 bpm
|
0.4 bpm
Standard Deviation 5.0
|
-0.3 bpm
Standard Deviation 8.3
|
|
Mean Change in Pulse From Baseline
Day 2 (24 hours post-dose)
|
-3.0 bpm
|
-0.2 bpm
Standard Deviation 5.2
|
3.7 bpm
Standard Deviation 6.7
|
|
Mean Change in Pulse From Baseline
Day 3 (48 hours post-dose)
|
-6.0 bpm
|
-1.4 bpm
Standard Deviation 6.5
|
3.5 bpm
Standard Deviation 3.3
|
|
Mean Change in Pulse From Baseline
Day 4 (72 hours post-dose)
|
-18.0 bpm
|
-4.2 bpm
Standard Deviation 3.8
|
5.7 bpm
Standard Deviation 7.9
|
|
Mean Change in Pulse From Baseline
Day 5 (96 hours post-dose)
|
-18.0 bpm
|
-1.8 bpm
Standard Deviation 4.8
|
2.0 bpm
Standard Deviation 7.6
|
|
Mean Change in Pulse From Baseline
Day 12
|
-4.0 bpm
|
-6.8 bpm
Standard Deviation 6.1
|
5.3 bpm
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, and 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 1 (12 hours post-dose)
|
-4.0 mmHg
|
2.0 mmHg
Standard Deviation 19.2
|
0.8 mmHg
Standard Deviation 4.4
|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 2 (24 hours post-dose)
|
-16.0 mmHg
|
-15.0 mmHg
Standard Deviation 14.9
|
-6.5 mmHg
Standard Deviation 7.5
|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 3 (48 hours post-dose)
|
-23.0 mmHg
|
-11.2 mmHg
Standard Deviation 14.0
|
0.3 mmHg
Standard Deviation 10.1
|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 4 (72 hours post-dose)
|
-20.0 mmHg
|
-3.4 mmHg
Standard Deviation 17.7
|
0.8 mmHg
Standard Deviation 8.1
|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 5 (96 hours post-dose)
|
-17.0 mmHg
|
-3.8 mmHg
Standard Deviation 13.5
|
0.5 mmHg
Standard Deviation 6.9
|
|
Mean Change in Sitting Systolic Blood Pressure From Baseline
Day 12
|
-13.0 mmHg
|
-5.4 mmHg
Standard Deviation 20.2
|
0.8 mmHg
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 5, and 12Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 3 (48 hours post-dose)
|
-7.0 mmHg
|
-2.2 mmHg
Standard Deviation 7.3
|
-0.5 mmHg
Standard Deviation 6.7
|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 4 (72 hours post-dose)
|
-6.0 mmHg
|
1.0 mmHg
Standard Deviation 11.2
|
1.2 mmHg
Standard Deviation 3.9
|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 5 (96 hours post-dose)
|
-4.0 mmHg
|
-2.4 mmHg
Standard Deviation 13.8
|
-0.5 mmHg
Standard Deviation 5.7
|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 12
|
-1.0 mmHg
|
-1.4 mmHg
Standard Deviation 10.3
|
-1.5 mmHg
Standard Deviation 6.0
|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 1 (12 hours post-dose)
|
3.0 mmHg
|
2.0 mmHg
Standard Deviation 9.8
|
1.3 mmHg
Standard Deviation 2.5
|
|
Mean Change in Sitting Diastolic Blood Pressure From Baseline
Day 2 (24 hours post-dose)
|
-6.0 mmHg
|
-2.4 mmHg
Standard Deviation 7.0
|
-3.7 mmHg
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Day 5Population: The safety analysis population set included all participants who receive any amount of study product.
The mean change from baseline was calculated by taking the mean of each participant value at the specified day minus the value last recorded prior to drug administration.
Outcome measures
| Measure |
ESRD Not on Dialysis
n=1 Participants
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 Participants
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
Healthy Matched Controls
n=6 Participants
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Mean Change in the Electrocardiogram (ECG) Corrected QT Interval by Fridericia (QTcF) Interval From Baseline
|
25.0 ms
|
-10.0 ms
Standard Deviation 10.9
|
5.3 ms
Standard Deviation 13.3
|
Adverse Events
Healthy Matched Controls
ESRD Not on Dialysis
Severe Renal Impairment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Matched Controls
n=6 participants at risk
Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid
|
ESRD Not on Dialysis
n=1 participants at risk
Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid
|
Severe Renal Impairment
n=5 participants at risk
Participants with severe renal impairment received a single oral dose of 200 mg pretomanid
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
0.00%
0/1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
20.0%
1/5 • Number of events 1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
0.00%
0/1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
20.0%
1/5 • Number of events 1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
0.00%
0/1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
20.0%
1/5 • Number of events 1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
0.00%
0/1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
20.0%
1/5 • Number of events 1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
0.00%
0/1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
20.0%
1/5 • Number of events 1 • Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
|
Additional Information
William Smith, MD
Alliance for Multispecialty Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60