Trial Outcomes & Findings for Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin (NCT NCT01770392)
NCT ID: NCT01770392
Last Updated: 2014-11-27
Results Overview
AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib
Results posted on
2014-11-27
Participant Flow
Participant milestones
| Measure |
Overall Study
This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
|
|---|---|
|
Nintedanib
STARTED
|
26
|
|
Nintedanib
COMPLETED
|
26
|
|
Nintedanib
NOT COMPLETED
|
0
|
|
Washout Period of at Least 14 Days
STARTED
|
26
|
|
Washout Period of at Least 14 Days
COMPLETED
|
25
|
|
Washout Period of at Least 14 Days
NOT COMPLETED
|
1
|
|
Nintedanib+ Rifampicin
STARTED
|
25
|
|
Nintedanib+ Rifampicin
COMPLETED
|
25
|
|
Nintedanib+ Rifampicin
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Overall Study
This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
|
|---|---|
|
Washout Period of at Least 14 Days
Adverse Event
|
1
|
Baseline Characteristics
Relative Bioavailability of a Single Dose of Nintedanib Given Alone and in Combination With Multiple Doses of Rifampicin
Baseline characteristics by cohort
| Measure |
Overall Study
n=26 Participants
This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
|
|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanibPopulation: TS
AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Nintedanib
n=26 Participants
150 mg of nintedanib was given as a single dose on Day 1.
|
Nintedanib + Rifampicin
n=25 Participants
600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
|
|---|---|---|
|
Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)
|
183 ng*h/mL
Geometric Coefficient of Variation 36.1
|
89.4 ng*h/mL
Geometric Coefficient of Variation 36.8
|
PRIMARY outcome
Timeframe: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanibPopulation: TS
Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Nintedanib
n=26 Participants
150 mg of nintedanib was given as a single dose on Day 1.
|
Nintedanib + Rifampicin
n=25 Participants
600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
|
|---|---|---|
|
Maximum Measured Concentration (Cmax)
|
22.1 ng/mL
Geometric Coefficient of Variation 51.8
|
12.8 ng/mL
Geometric Coefficient of Variation 43.4
|
SECONDARY outcome
Timeframe: 1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanibPopulation: TS
AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration. For this endpoint, the "measured values" show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.
Outcome measures
| Measure |
Nintedanib
n=26 Participants
150 mg of nintedanib was given as a single dose on Day 1.
|
Nintedanib + Rifampicin
n=25 Participants
600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
|
|---|---|---|
|
Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)
|
173 ng*h/mL
Geometric Coefficient of Variation 36.9
|
84.1 ng*h/mL
Geometric Coefficient of Variation 38.1
|
Adverse Events
Nintedanib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Washout Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Rifampicin
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Nintedanib + Rifampicin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nintedanib
n=26 participants at risk
150 mg of nintedanib was given as a single dose on Day 1.
|
Washout Period
n=26 participants at risk
washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
|
Rifampicin
n=25 participants at risk
600 mg rifampicin was given every evening from Day -7 to Day -1
|
Nintedanib + Rifampicin
n=25 participants at risk
600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
8.0%
2/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
7.7%
2/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
20.0%
5/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
8.0%
2/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
19.2%
5/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
4.0%
1/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
12.0%
3/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
12.0%
3/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
8.0%
2/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
100.0%
25/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
|
General disorders
Fatigue
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/26 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
8.0%
2/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
0.00%
0/25 • From the first trial drug administration until up to 14 days after last trial drug administration, up to 28 days
|
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