A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

Sponsor
Boehringer Ingelheim
Study ID
NCT05945888
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.

Key Dates

Start date
Jul 25, 2023
Status verified
May 2026
Primary completion
Nov 13, 2023
Completion
Nov 13, 2023

Study Design

Enrollment
68 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Single rising dose (SRD): Placebo matching BI 3000202
    SRD part: A single administration of 1 film-coated tablet identical to the active BI 3000202 treatment was orally given with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
  • Experimental: SRD: Dose 1 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 1) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 2 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 2) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 3 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 3) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 4 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 4) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 5 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 5) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 6 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 6) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: SRD: Dose 7 - BI 3000202
    SRD part: A single dose of BI 3000202 film-coated tablet(s) (dose 7) was administered orally with 240 mL of water after a minimum 10-hour overnight fast.
  • Experimental: Food effect (FE): Low dose III BI 3000202 fasted (R) / fed (T)
    FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water after an overnight fast of at least 10 hours (= reference R). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). There was a minimum 3-day washout period between the two treatments.
  • Experimental: FE: Low dose III BI 3000202 fed (T) / fasted (R)
    FE part: In treatment Period 1, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after consuming a high-fat, high-calorie breakfast consumed after an overnight fast of at least 10 hours (=test T). In treatment Period 2, participants received a low dose III film-coated tablet BI 3000202, orally administered with 240 mL of water 30 minutes after an overnight fast of at least 10 hours (= reference R). There was a minimum 3-day washout period between the two treatments.

Primary Outcome Measure

SRD Part: Number of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator [ Time Frame: From drug administration on Day 1 plus REP of 48 hours, up to 2 days. ]

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