A Study in Healthy Japanese Men to Test How Different Doses of BI 894416 Are Tolerated

NCT04540874 | Terminated Phase 1 Results

• 1 other identifier: 1371-0003
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to investigate the safety, tolerability and pharmacokinetics of BI 894416 in healthy Japanese male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug Related Adverse Events

  The percentage of participants with drug related adverse events was reported.

  From drug administration until end of follow-up, up to 17 days.

Secondary Outcomes (2)

• Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Within 1 hour (h) before drug administration and at 15 minutes (min), 30min, 45min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

• Maximum Measured Concentration of BI 894416 in Plasma (Cmax)

  Within 1 hour (h) before drug administration and at 15 minutes (min), 30min, 45min, 1h, 1h30min, 2h, 2h30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.

Study Arms (2)

BI 894416 25mg

EXPERIMENTAL

1 tablet of 25 milligrams (mg) BI 894416 was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.

Drug: BI 894416

Placebo group

PLACEBO COMPARATOR

Matching placebo was administered orally as single dose with 240 milliliters of water after an overnight fast of at least 10 hours on day 1, followed by at least 48 hours close medical surveillance, followed by 2 weeks of follow-up period.

Drug: Placebo

Interventions

BI 894416 DRUG

BI 894416

BI 894416 25mg

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
• Japanese ethnicity, according to the following criteria:
• \- born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
• Age of 20 to 45 years (inclusive) at screening
• BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening
• Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
• Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
• Use of adequate contraception, any of the following methods plus condom:
• intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
• Vasectomized (vasectomy at least 1 year prior to enrolment)
• Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
• Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Clinical Research Hospital Tokyo

Tokyo, Shinjuku-ku, 162-0053, Japan

Location

Related Links

• Related Info

Limitations and Caveats

The study was terminated by the sponsor after the first dosage group (25 mg BI 894416), only a subset of the analyses planned in the protocol was performed. No dose-proportionality analysis was done. Secondary endpoints were analysed descriptively only.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 7, 2020
• Study Start: October 5, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)