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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BI 894416

• Registration Number: NCT04540874
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Study Start: 2020-10-05
• Primary Completion: 2020-11-12
• Study Completion: 2020-11-12
• Status Verified: 2022-09
• Results First Submitted: 2022-09-26
• Results First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Results First Posted: 2023-08-16
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1. 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

2. 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

3. Age of 20 to 45 years (inclusive) at screening

4. BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening

5. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation

6. 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

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Exclusion Criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. 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
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
7. Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	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.
BI 894416 25mg	BI 894416	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Drug Related Adverse Events	From drug administration until end of follow-up, up to 17 days.	The percentage of participants with drug related adverse events was reported.

Secondary Outcome Measures

Name	Time	Method
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.	Maximum measured concentration of BI 894416 in plasma was reported.
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.	Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity was reported.

Trial Locations

Locations (1)

Clinical Research Hospital Tokyo; 🇯🇵 Tokyo, Shinjuku-ku, Japan