Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects (NCT NCT01737996)
NCT ID: NCT01737996
Last Updated: 2016-04-08
Results Overview
Number of healthy subjects with any adverse event (AE) during the on-treatment period.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Results posted on
2016-04-08
Participant Flow
The 600mg dose cohort was to be started at least 6 days after the 400mg dose cohort was completed and the combined treatment cohort (600mg Deleobuvir + 120mg Faldaprevir) was started after the evaluation of key safety and tolerability data of the individual treatments.
Participant milestones
| Measure |
400 mg Deleobuvir
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
|
600 mg Deleobuvir + 120 mg Faldaprevir
600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
16
|
|
Overall Study
COMPLETED
|
8
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
400 mg Deleobuvir
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
|
600 mg Deleobuvir + 120 mg Faldaprevir
600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects
Baseline characteristics by cohort
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=8 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
600 mg Deleobuvir + 120 mg Faldaprevir
n=16 Participants
600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)Population: Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.
Number of healthy subjects with any adverse event (AE) during the on-treatment period.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=8 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Number of Healthy Subjects With AEs (Multiple Rising Dose Part)
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.Population: PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.
Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)
AUC(0-12h) on Day 1
|
37500 nmol*h/L
Geometric Coefficient of Variation 49.4
|
—
|
|
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)
AUC(0-12h,ss) on Day 16
|
51400 nmol*h/L
Geometric Coefficient of Variation 57.2
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.
Outcome measures
| Measure |
400 mg Deleobuvir
n=15 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)
Cmax on Day 1
|
6930 nmol/L
Geometric Coefficient of Variation 47.9
|
—
|
|
Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)
Cmax,ss on Day 16 (N=14)
|
9710 nmol/L
Geometric Coefficient of Variation 43.3
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)
C(12h) on Day 1
|
1090 nmol/L
Geometric Coefficient of Variation 69.3
|
—
|
|
C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)
C(12h,ss) on Day 16
|
1000 nmol/L
Geometric Coefficient of Variation 85.9
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)
AUC(0-12h) on Day 1
|
6080 nmol*h/L
Geometric Coefficient of Variation 55.0
|
—
|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)
AUC(0-12h,ss) on Day 16
|
38100 nmol*h/L
Geometric Coefficient of Variation 76.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)
Cmax on Day 1
|
902 nmol/L
Geometric Coefficient of Variation 49.2
|
—
|
|
Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)
Cmax,ss on Day 16
|
4860 nmol/L
Geometric Coefficient of Variation 60.5
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)
C(12h) on Day 1
|
488 nmol/L
Geometric Coefficient of Variation 67.5
|
—
|
|
C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)
C(12h,ss) on Day 16
|
1650 nmol/L
Geometric Coefficient of Variation 102.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)
AUC(0-12h) on Day 1
|
9130 nmol*h/L
Geometric Coefficient of Variation 46.9
|
—
|
|
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)
AUC(0-12h,ss) on Day 16
|
13600 nmol*h/L
Geometric Coefficient of Variation 71.1
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=15 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)
Cmax on Day 1
|
1450 nmol/L
Geometric Coefficient of Variation 40.0
|
—
|
|
Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)
Cmax,ss on Day 16 (N=14)
|
2060 nmol/L
Geometric Coefficient of Variation 57.6
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. BI 208333 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)
C(12h) on Day 1
|
520 nmol/L
Geometric Coefficient of Variation 80.8
|
—
|
|
C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)
C(12h,ss) on Day 16
|
447 nmol/L
Geometric Coefficient of Variation 101.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
AUC(0-12h) on Day 1
|
511 nmol*h/L
Geometric Coefficient of Variation 69.9
|
—
|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
AUC(0-12h,ss) on Day 16
|
3560 nmol*h/L
Geometric Coefficient of Variation 120.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=15 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)
Cmax on Day 1
|
83.9 nmol/L
Geometric Coefficient of Variation 63.7
|
—
|
|
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)
Cmax,ss on Day 16 (N=14)
|
457.0 nmol/L
Geometric Coefficient of Variation 106.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
C(12h) on Day 1
|
56.4 nmol/L
Geometric Coefficient of Variation 67.1
|
—
|
|
C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)
C(12h,ss) on Day 16
|
178.0 nmol/L
Geometric Coefficient of Variation 122.0
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.
Outcome measures
| Measure |
400 mg Deleobuvir
n=14 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)
AUC(0-12h) on Day 1
|
44800 nmol*h/L
Geometric Coefficient of Variation 23.6
|
—
|
|
AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)
AUC(0-12h,ss) on Day 16
|
66200 nmol*h/L
Geometric Coefficient of Variation 46.1
|
—
|
PRIMARY outcome
Timeframe: After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.
Outcome measures
| Measure |
400 mg Deleobuvir
n=15 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)
Cmax on Day 1
|
4060.0 nmol/L
Geometric Coefficient of Variation 25.0
|
—
|
|
Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)
Cmax,ss on Day 16 (N=14)
|
5940.0 nmol/L
Geometric Coefficient of Variation 32.3
|
—
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)
AUC(0-12h) on Day 1
|
8210 nmol*h/L
Geometric Coefficient of Variation 45.5
|
18000 nmol*h/L
Geometric Coefficient of Variation 77.6
|
|
AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)
AUC(0-12h,ss) on Day 9
|
6160 nmol*h/L
Geometric Coefficient of Variation 45.2
|
18500 nmol*h/L
Geometric Coefficient of Variation 93.3
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)
Cmax on Day 1
|
2010 nmol/L
Geometric Coefficient of Variation 41.5
|
3740 nmol/L
Geometric Coefficient of Variation 79.4
|
|
Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)
Cmax,ss on Day 9
|
1380 nmol/L
Geometric Coefficient of Variation 48.3
|
3650 nmol/L
Geometric Coefficient of Variation 91.6
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)
AUC(0-12h) on Day 1
|
1690 nmol*h/L
Geometric Coefficient of Variation 56.0
|
2920 nmol*h/L
Geometric Coefficient of Variation 88.3
|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)
AUC(0-12h,ss) on Day 9
|
2810 nmol*h/L
Geometric Coefficient of Variation 63.1
|
6960 nmol*h/L
Geometric Coefficient of Variation 106.0
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9. CD 6168 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)
Cmax on Day 1
|
329 nmol/L
Geometric Coefficient of Variation 60.5
|
516 nmol/L
Geometric Coefficient of Variation 92.7
|
|
Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)
Cmax,ss on Day 9
|
451 nmol/L
Geometric Coefficient of Variation 66.3
|
1130 nmol/L
Geometric Coefficient of Variation 90.9
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)
AUC(0-12h) on Day 1
|
3940 nmol*h/L
Geometric Coefficient of Variation 38.7
|
6060 nmol*h/L
Geometric Coefficient of Variation 57.1
|
|
AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)
AUC(0-12h,ss) on Day 9
|
2840 nmol*h/L
Geometric Coefficient of Variation 51.7
|
5270 nmol*h/L
Geometric Coefficient of Variation 102.0
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9. BI 208333 is a major metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)
Cmax on Day 1
|
766 nmol/L
Geometric Coefficient of Variation 41.5
|
1050 nmol/L
Geometric Coefficient of Variation 54.2
|
|
Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)
Cmax,ss on Day 9
|
576 nmol/L
Geometric Coefficient of Variation 44.4
|
983 nmol/L
Geometric Coefficient of Variation 82.4
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=7 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
AUC(0-12h) on Day 1
|
155 nmol*h/L
Geometric Coefficient of Variation 27.2
|
342 nmol*h/L
Geometric Coefficient of Variation 66.0
|
|
AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
AUC(0-12h,ss) on Day 9 (N=6, 7)
|
256 nmol*h/L
Geometric Coefficient of Variation 42.7
|
701 nmol*h/L
Geometric Coefficient of Variation 94.0
|
SECONDARY outcome
Timeframe: After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.Population: PKS including patients with available data.
Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9. CD 6168 acylglucuronide is a metabolite of Deleobuvir.
Outcome measures
| Measure |
400 mg Deleobuvir
n=8 Participants
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=7 Participants
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
|---|---|---|
|
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Cmax,ss on Day 9
|
33.3 nmol/L
Geometric Coefficient of Variation 61.3
|
116.0 nmol/L
Geometric Coefficient of Variation 80.6
|
|
Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)
Cmax on Day 1
|
27.3 nmol/L
Geometric Coefficient of Variation 36.8
|
57.9 nmol/L
Geometric Coefficient of Variation 61.0
|
Adverse Events
400 mg Deleobuvir
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
600 mg Deleobuvir
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
600 mg Deleobuvir + 120 mg Faldaprevir
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
400 mg Deleobuvir
n=8 participants at risk
400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
|
600 mg Deleobuvir
n=8 participants at risk
600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
|
600 mg Deleobuvir + 120 mg Faldaprevir
n=16 participants at risk
600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.
Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part.
|
|---|---|---|---|
|
Infections and infestations
Folliculitis
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
18.8%
3/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Cheilitis
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
31.2%
5/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
37.5%
3/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
25.0%
4/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
2/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
General disorders
Fatigue
|
12.5%
1/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
12.5%
2/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
|
Investigations
Transaminases increased
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
0.00%
0/8 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
6.2%
1/16 • From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)
Subjects were required to report spontaneously any AEs. In addition, each subject was assessed by the investigator at pre-defined timepoints and whenever it was deemed necessary by the investigator.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER