Trial Outcomes & Findings for Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan (NCT NCT01311362)
NCT ID: NCT01311362
Last Updated: 2017-05-31
Results Overview
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
after first dose, at steady-state, during St John's wort
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Ambrisentan After First Dose
administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
|
|---|---|
|
Ambrisentan Single Dose
STARTED
|
20
|
|
Ambrisentan Single Dose
COMPLETED
|
20
|
|
Ambrisentan Single Dose
NOT COMPLETED
|
0
|
|
Ambrisentan Steady-state
STARTED
|
20
|
|
Ambrisentan Steady-state
COMPLETED
|
20
|
|
Ambrisentan Steady-state
NOT COMPLETED
|
0
|
|
Ambrisentan and SJW
STARTED
|
20
|
|
Ambrisentan and SJW
COMPLETED
|
20
|
|
Ambrisentan and SJW
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan
Baseline characteristics by cohort
| Measure |
Ambrisentan
n=20 Participants
administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
|
|---|---|
|
Age, Continuous
|
31.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after first dose, at steady-state, during St John's wortOutcome measures
| Measure |
Ambrisentan After First Dose
n=20 Participants
administration of ambrisentan 5 mg p.o. single dose
|
Ambrisentan at Steady-state
n=20 Participants
administration of ambrisentan 5 mg p.o. q.d. on day 3-10
|
Ambrisentan During St John's Wort
n=20 Participants
administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
|
|---|---|---|---|
|
AUC of Ambrisentan
|
3670 h*ng/ml
Interval 3200.0 to 4220.0
|
3520 h*ng/ml
Interval 3120.0 to 3970.0
|
2790 h*ng/ml
Interval 2470.0 to 3150.0
|
PRIMARY outcome
Timeframe: after first dose, at steady-state and during St John's wortOutcome measures
| Measure |
Ambrisentan After First Dose
n=20 Participants
administration of ambrisentan 5 mg p.o. single dose
|
Ambrisentan at Steady-state
n=20 Participants
administration of ambrisentan 5 mg p.o. q.d. on day 3-10
|
Ambrisentan During St John's Wort
n=20 Participants
administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
|
|---|---|---|---|
|
Cmax of Ambrisentan
|
447 ng/ml
Interval 397.0 to 502.0
|
456 ng/ml
Interval 399.0 to 521.0
|
383 ng/ml
Interval 331.0 to 444.0
|
Adverse Events
Ambrisentan After First Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ambrisentan at Steady-state
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ambrisentan During St John's Wort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ambrisentan After First Dose
n=20 participants at risk
administration of ambrisentan 5 mg p.o. single dose
|
Ambrisentan at Steady-state
n=20 participants at risk
administration of ambrisentan 5 mg p.o. q.d. on day 3-10
|
Ambrisentan During St John's Wort
n=20 participants at risk
administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
|
|---|---|---|---|
|
General disorders
Headache
|
45.0%
9/20
|
45.0%
9/20
|
20.0%
4/20
|
|
Hepatobiliary disorders
increase of liver transaminases
|
15.0%
3/20
|
15.0%
3/20
|
0.00%
0/20
|
|
General disorders
nasal congestion
|
25.0%
5/20
|
25.0%
5/20
|
10.0%
2/20
|
|
General disorders
Back pain
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
Nasopharyngitis
|
5.0%
1/20
|
5.0%
1/20
|
10.0%
2/20
|
|
General disorders
heart palpitation
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
heat sensation
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
thoracic discomfort
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
flush
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
pressure sensation in head
|
5.0%
1/20
|
5.0%
1/20
|
5.0%
1/20
|
|
General disorders
diarrhoea
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
|
General disorders
nightmares
|
5.0%
1/20
|
5.0%
1/20
|
0.00%
0/20
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place