Trial Outcomes & Findings for Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA) (NCT NCT03510468)
NCT ID: NCT03510468
Last Updated: 2024-08-13
Results Overview
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TAF was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ®
COMPLETED
PHASE1
51 participants
0-24 hours post dosing on days 14, 22, and 31
2024-08-13
Participant Flow
Of the 51 participants consented to the study, 17 were screen failure and 6 withdrew prior to start of study.
Participant milestones
| Measure |
Pharmacokinetic Study in Healthy Volunteers
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Pharmacokinetic Study in Healthy Volunteers
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
non-compliant with treatment
|
2
|
|
Overall Study
Missed visit
|
1
|
Baseline Characteristics
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
Baseline characteristics by cohort
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=28 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hours post dosing on days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TAF was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ®
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=20 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Plasma Area Under the Curve (AUC) for Tenofovir Alafenamide (TAF) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 14
|
295.5 hr*ng/ml
Geometric Coefficient of Variation 64
|
|
Plasma Area Under the Curve (AUC) for Tenofovir Alafenamide (TAF) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 22
|
472.1 hr*ng/ml
Geometric Coefficient of Variation 59
|
|
Plasma Area Under the Curve (AUC) for Tenofovir Alafenamide (TAF) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 31
|
248.1 hr*ng/ml
Geometric Coefficient of Variation 88
|
PRIMARY outcome
Timeframe: 0-24 hours post dosing on days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TFV was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ®
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=21 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 14
|
262.2 hr*ng/ml
Geometric Coefficient of Variation 45
|
|
Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 22
|
265.3 hr*ng/ml
Geometric Coefficient of Variation 38
|
|
Plasma Area Under the Curve (AUC) for Tenofovir (TFV) During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 31
|
230.8 hr*ng/ml
Geometric Coefficient of Variation 45
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Maximum total plasma concentration (Cmax) following a 25mg dose of TAF on day 14, 22, and 31. Cmax for TAF was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=23 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir Alafenamide (TAF)
Day 14
|
208.9 ng/mL
Geometric Coefficient of Variation 88
|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir Alafenamide (TAF)
Day 22
|
335.2 ng/mL
Geometric Coefficient of Variation 61
|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir Alafenamide (TAF)
Day 31
|
179.1 ng/mL
Geometric Coefficient of Variation 80
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Maximum total plasma concentration (Cmax) following a 25mg dose of tenofovir alafenamide (TAF) on day 14, 22, and 31. Cmax for TFV was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=22 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir (TFV)
Day 14
|
16.5 ng/mL
Geometric Coefficient of Variation 79
|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir (TFV)
Day 22
|
16.5 ng/mL
Geometric Coefficient of Variation 37
|
|
Maximum Total Plasma Concentration (Cmax) for Tenofovir (TFV)
Day 31
|
13.8 ng/mL
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Time to maximum total plasma concentration (Cmax) following a 25mg dose of TAF on day 14, 22, and 31. Tmax for TAF was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=23 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir Alafenamide (TAF)
Day 14
|
0.5 Hours
Interval 0.25 to 2.0
|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir Alafenamide (TAF)
Day 22
|
0.57 Hours
Interval 0.25 to 2.0
|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir Alafenamide (TAF)
Day 31
|
0.5 Hours
Interval 0.25 to 2.0
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Time to maximum total plasma concentration (Cmax) following a 25mg dose of TAF on day 14, 22, and 31. Tmax for TFV was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=22 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir (TFV)
Day 14
|
4 Hours
Interval 0.25 to 8.0
|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir (TFV)
Day 22
|
4 Hours
Interval 1.0 to 4.1
|
|
Time to Maximum Plasma Concentration (Tmax) for Tenofovir (TFV)
Day 31
|
4 Hours
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Half-life calculated as natural log of 2 \[ln(2)\]/lambda Z of TFV on day 14, 22, and 31.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=15 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Terminal Half-life (t½) of Tenofovir (TFV)
Day 14
|
39.8 Hours
Geometric Coefficient of Variation 47
|
|
Terminal Half-life (t½) of Tenofovir (TFV)
Day 22
|
42.6 Hours
Geometric Coefficient of Variation 24
|
|
Terminal Half-life (t½) of Tenofovir (TFV)
Day 31
|
33.5 Hours
Geometric Coefficient of Variation 80
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Apparent oral clearance of TAF was calculated as "dose/plasma area under the curve (AUC)" on day 14, 22, and 31.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=20 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Apparent Oral Clearance (CL/F) of Tenofovir Alafenamide (TAF)
Day 14
|
84.6 L/hr
Geometric Coefficient of Variation 64
|
|
Apparent Oral Clearance (CL/F) of Tenofovir Alafenamide (TAF)
Day 22
|
52.9 L/hr
Geometric Coefficient of Variation 59
|
|
Apparent Oral Clearance (CL/F) of Tenofovir Alafenamide (TAF)
Day 31
|
100.8 L/hr
Geometric Coefficient of Variation 88
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Minimum total plasma concentration (Cmin) following a 25mg dose of TAF on day 14, 22, and 31. Cmin for TAF was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=23 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir Alafenamide (TAF)
Day 14
|
2.4 ng/mL
Standard Deviation 4.5
|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir Alafenamide (TAF)
Day 22
|
2.9 ng/mL
Standard Deviation 6
|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir Alafenamide (TAF)
Day 31
|
2 ng/mL
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Minimum total plasma concentration (Cmin) following a 25mg dose of tenofovir alafenamide (TAF) on day 14, 22, and 31. Cmin for TFV was obtained directly by visual inspection of the plasma concentration versus time profiles over 24 hours postdose.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=22 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir (TFV)
Day 14
|
9.1 ng/mL
Standard Deviation 4.2
|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir (TFV)
Day 22
|
7.2 ng/mL
Standard Deviation 3.2
|
|
Minimum Total Plasma Concentration (Cmin) for Tenofovir (TFV)
Day 31
|
8.7 ng/mL
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 0-24 hours post dosing on days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of intracellular tenofovir di-phosphate using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ®
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=23 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Plasma Area Under the Curve (AUC) for Intracellular Tenofovir Di-phosphate During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 22
|
NA hr*ng/ml
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
|
Plasma Area Under the Curve (AUC) for Intracellular Tenofovir Di-phosphate During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 31
|
NA hr*ng/ml
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
|
Plasma Area Under the Curve (AUC) for Intracellular Tenofovir Di-phosphate During the Dosing Interval of 0 to 24 Hours (AUC0-24hr)
Day 14
|
NA hr*ng/ml
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
SECONDARY outcome
Timeframe: Days 14, 22, and 31Population: All participants who completed at least one intensive pharmacokinetic visit were included in the pharmacokinetics analysis.
Half-life calculated as natural log of 2\[ ln(2)\]/lambda Z of TFV on day 14, 22, and 31.
Outcome measures
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=23 Participants
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Terminal Half-life (t½) of Intracellular Tenofovir-diphosphate
Day 14
|
NA Hours
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
|
Terminal Half-life (t½) of Intracellular Tenofovir-diphosphate
Day 22
|
NA Hours
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
|
Terminal Half-life (t½) of Intracellular Tenofovir-diphosphate
Day 31
|
NA Hours
Geometric Coefficient of Variation NA
Insufficient drug concentrations above intracellular assay lower limit of quantification (LLOQ)
|
Adverse Events
Pharmacokinetic Study in Healthy Volunteers
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pharmacokinetic Study in Healthy Volunteers
n=28 participants at risk
Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg/kg (up to 900 mg) once weekly from days 15-31.
|
|---|---|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Up to day 49
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.6%
1/28 • Up to day 49
|
|
Ear and labyrinth disorders
Ear pain
|
3.6%
1/28 • Up to day 49
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
2/28 • Up to day 49
|
|
Gastrointestinal disorders
Abdominal pain
|
10.7%
3/28 • Up to day 49
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
1/28 • Up to day 49
|
|
Gastrointestinal disorders
Abdominal tenderness
|
3.6%
1/28 • Up to day 49
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Up to day 49
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
4/28 • Up to day 49
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Up to day 49
|
|
Gastrointestinal disorders
Nausea
|
17.9%
5/28 • Up to day 49
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Up to day 49
|
|
General disorders
Chills
|
7.1%
2/28 • Up to day 49
|
|
General disorders
Facial pain
|
3.6%
1/28 • Up to day 49
|
|
General disorders
Fatigue
|
7.1%
2/28 • Up to day 49
|
|
Infections and infestations
COVID-19
|
3.6%
1/28 • Up to day 49
|
|
Infections and infestations
Rhinitis
|
7.1%
2/28 • Up to day 49
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
3.6%
1/28 • Up to day 49
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Up to day 49
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.6%
1/28 • Up to day 49
|
|
Investigations
Alanine aminotransferase increased
|
10.7%
3/28 • Up to day 49
|
|
Investigations
Amylase increased
|
17.9%
5/28 • Up to day 49
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
1/28 • Up to day 49
|
|
Investigations
Blood bicarbonate decreased
|
7.1%
2/28 • Up to day 49
|
|
Investigations
Blood bilirubin increased
|
17.9%
5/28 • Up to day 49
|
|
Investigations
Blood cholesterol increased
|
17.9%
5/28 • Up to day 49
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
2/28 • Up to day 49
|
|
Investigations
Blood glucose decreased
|
3.6%
1/28 • Up to day 49
|
|
Investigations
Blood glucose increased
|
10.7%
3/28 • Up to day 49
|
|
Investigations
Blood phosphorus decreased
|
14.3%
4/28 • Up to day 49
|
|
Investigations
Blood potassium decreased
|
7.1%
2/28 • Up to day 49
|
|
Investigations
Blood sodium decreased
|
10.7%
3/28 • Up to day 49
|
|
Investigations
Blood sodium increased
|
7.1%
2/28 • Up to day 49
|
|
Investigations
Blood triglycerides increased
|
7.1%
2/28 • Up to day 49
|
|
Investigations
C-reactive protein increased
|
10.7%
3/28 • Up to day 49
|
|
Investigations
Lipase increased
|
21.4%
6/28 • Up to day 49
|
|
Investigations
Low density lipoprotein increased
|
3.6%
1/28 • Up to day 49
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.6%
1/28 • Up to day 49
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Up to day 49
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.6%
1/28 • Up to day 49
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
5/28 • Up to day 49
|
|
Nervous system disorders
Depressed level of consciousness
|
3.6%
1/28 • Up to day 49
|
|
Nervous system disorders
Dizziness
|
14.3%
4/28 • Up to day 49
|
|
Nervous system disorders
Headache
|
42.9%
12/28 • Up to day 49
|
|
Nervous system disorders
Loss of consciousness
|
3.6%
1/28 • Up to day 49
|
|
Nervous system disorders
Memory impairment
|
3.6%
1/28 • Up to day 49
|
|
Nervous system disorders
Migraine
|
3.6%
1/28 • Up to day 49
|
|
Nervous system disorders
Paraesthesia
|
3.6%
1/28 • Up to day 49
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Up to day 49
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Up to day 49
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
3/28 • Up to day 49
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.6%
1/28 • Up to day 49
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
2/28 • Up to day 49
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.6%
1/28 • Up to day 49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place