Clinical trial NCT02853136
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2016-08-25; Completion date: 2016-10-25
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the influence of fluvoxamine on the pharmacokinetics of BI 409306

Detailed description:

Arms: arm 1: The subjects were administered 3 milligram \[mg\] BI 409306 Powder for Oral Solution \[PfOS\] single dose for one day in the pilot phase, taken as 6 mL of 0.5 mg/mL BI 409306 solved in 5 mg/mL \[milliLiter\] tartaric acid orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.

Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.

There was a washout of at least 3 days after administration of BI 409306 in R1. arm 2: The subjects were administered 3 mg BI 409306 PfOS single dose for one day in the pilot phase together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 3 mg BI 409306 PfOS single dose for one day orally with 240 mL of water after an overnight fast of at least 10h.

Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.

There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T1. arm 3: The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 film-coated tablet single dose for one day together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h.

Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.

There was a washout of at least 3 days after administration of BI 409306 in R2. arm 4: The subjects were administered 10 mg BI 409306 film-coated tablet single dose for one day in the main phase together with 100 mg Fluvoxamine \[Fevarin®\] film-coated tablet once daily orally with 240 mL of water after an overnight fast of at least 10h, followed by 10 mg BI 409306 single dose film-coated tablet for one day orally with 240 mL of water after an overnight fast of at least 10h.

Prior to the combined treatment, Fluvoxamine was given for 3 days: 50 mg twice daily on Day -3, followed by 100 mg bid on Day -2 and Day -1.

There was a washout of at least 6 days after combined administration of BI 409306 and Fluvoxamine in T2.
Interventions: intervention 1: Fluvoxamine intervention 2: BI 409306 - Powder for oral solution (PfOS) intervention 3: BI 409306 - film coated tablet
Intervention descriptions: intervention 1: Fluvoxamine intervention 2: BI 409306 - Powder for oral solution (PfOS) intervention 3: BI 409306 - film coated tablet

Protocol documents: