Trial Outcomes & Findings for Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan (NCT NCT01258504)
NCT ID: NCT01258504
Last Updated: 2017-05-31
Results Overview
Recruitment status
COMPLETED
Target enrollment
13 participants
Primary outcome timeframe
0-infinity; during dosing interval
Results posted on
2017-05-31
Participant Flow
Participant milestones
| Measure |
Bosentan
bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
|
|---|---|
|
Bosentan Single Dose
STARTED
|
13
|
|
Bosentan Single Dose
COMPLETED
|
13
|
|
Bosentan Single Dose
NOT COMPLETED
|
0
|
|
Bosentan Steady-state
STARTED
|
13
|
|
Bosentan Steady-state
COMPLETED
|
13
|
|
Bosentan Steady-state
NOT COMPLETED
|
0
|
|
Bosentan and SJW
STARTED
|
13
|
|
Bosentan and SJW
COMPLETED
|
13
|
|
Bosentan and SJW
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan
Baseline characteristics by cohort
| Measure |
Bosentan
n=13 Participants
bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
|
|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-infinity; during dosing intervalOutcome measures
| Measure |
Bosentan After First Dose
n=13 Participants
bosentan 125 mg p.o. day 1 single dose
|
Bosentan at Steady-state
n=13 Participants
bosentan 62.5 mg p.o. b.i.d. day 2-10
|
Bosentan During St John's Wort
n=13 Participants
bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
|
|---|---|---|---|
|
AUC of Bosentan
|
9540 h*ng/ml
Interval 7630.0 to 12000.0
|
5710 h*ng/ml
Interval 4530.0 to 7200.0
|
5020 h*ng/ml
Interval 2910.0 to 8690.0
|
PRIMARY outcome
Timeframe: after first dose, at steady-state and during SJWOutcome measures
| Measure |
Bosentan After First Dose
n=13 Participants
bosentan 125 mg p.o. day 1 single dose
|
Bosentan at Steady-state
n=13 Participants
bosentan 62.5 mg p.o. b.i.d. day 2-10
|
Bosentan During St John's Wort
n=13 Participants
bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
|
|---|---|---|---|
|
Cmax of Bosentan
|
1620 ng/ml
Interval 1170.0 to 2240.0
|
1370 ng/ml
Interval 1050.0 to 1790.0
|
1280 ng/ml
Interval 707.0 to 2300.0
|
Adverse Events
Bosentan After First Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Bosentan at Steady-state
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Bosentan During St John's Wort
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 |
Bosentan After First Dose
n=13 participants at risk
bosentan 125 mg p.o. day 1 single dose
|
Bosentan at Steady-state
n=13 participants at risk
bosentan 62.5 mg p.o. b.i.d. day 2-10
|
Bosentan During St John's Wort
n=13 participants at risk
bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
|
|---|---|---|---|
|
General disorders
feeling of heat
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
headache
|
30.8%
4/13
|
30.8%
4/13
|
7.7%
1/13
|
|
General disorders
dyspnea
|
7.7%
1/13
|
0.00%
0/13
|
0.00%
0/13
|
|
General disorders
increase of alanine aminotransferase
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
pressure sensation in the head
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
epigastric pressure sensation
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
nasopharyngitis
|
7.7%
1/13
|
7.7%
1/13
|
15.4%
2/13
|
|
General disorders
nausea
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
strained muscle
|
7.7%
1/13
|
7.7%
1/13
|
0.00%
0/13
|
|
General disorders
nasal congestion
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13
|
|
General disorders
ocular itching with secretion of tears
|
0.00%
0/13
|
0.00%
0/13
|
7.7%
1/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place