At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Male Subjects (Partially Randomised, Single-blind, Placebo-controlled) and Investigation of Relative Bioavailability and Food Effect of BI 425809 (Open-label, Randomised, Three-way Crossover)
In Brief
A Phase 1 clinical trial evaluating BI 425809 PfOS, Placebo PfOS, and 1 other intervention for Healthy. Completed, enrolled 83 participants across 1 site.
Detailed Summary
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
Study Details
Timeline
Arms & Interventions
Participants received a single dose of oral solution of placebo matching BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 0.5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 1 milligram (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 2 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 5 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 10 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 25 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 50 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 100 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants received a single dose of oral solution containing 150 milligrams (mg) of BI 425809. SRD = Single Rising Dose.
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Participants were administered 25 mg of BI 425809 as a tablet without food (reference treatment R), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Participants were administered 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1), and 25 mg of BI 425809 as a tablet without food (reference treatment R). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Participants were administered 25 mg of BI 425809 as a powder in an oral solution without food (test treatment T2), 25 mg of BI 425809 as a tablet without food (reference treatment R), and 25 mg of BI 425809 as a tablet after a standardized high-fat, high-calorie meal (test treatment T1). The 3 treatments were separated by a washout period of at least 14 days. BA = Bioavailability, FE = Food Effect.
Interventions
BI 425809 as a powder for an oral solution (PfOS)
Placebo as a powder for an oral solution (PfOS)
BI 425809 as a tablet