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Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

NCT ID: NCT02068690

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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BI 425809 single rising dose

BI 425809 powder for oral solution (PfOS) in single rising doses

Group Type EXPERIMENTAL

BI 425809 PfOS

Intervention Type DRUG

BI 425809 PfOS

Placebo

Intervention Type DRUG

Placebo

BI 425809 Crossover

Bioavailability of BI 425809 PfOS

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo

BI 425809 tablet

Intervention Type DRUG

BI 425809 tablet

BI 425809 PfOS

Intervention Type DRUG

BI 425809 PfOS

Interventions

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BI 425809 PfOS

BI 425809 PfOS

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

BI 425809 tablet

BI 425809 tablet

Intervention Type DRUG

BI 425809 PfOS

BI 425809 PfOS

Intervention Type DRUG

Other Intervention Names

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Iclepertin Iclepertin Iclepertin

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects
* Age 18 to 45 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Subject must be able to understand and comply with study requirements

Exclusion Criteria

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or pulse rate \<50 or \>90
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
* Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1346.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, , Germany

Site Status

Countries

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Germany

References

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Moschetti V, Desch M, Goetz S, Liesenfeld KH, Rosenbrock H, Kammerer KP, Wunderlich G, Wind S. Safety, Tolerability and Pharmacokinetics of Oral BI 425809, a Glycine Transporter 1 Inhibitor, in Healthy Male Volunteers: A Partially Randomised, Single-Blind, Placebo-Controlled, First-in-Human Study. Eur J Drug Metab Pharmacokinet. 2018 Apr;43(2):239-249. doi: 10.1007/s13318-017-0440-z.

Reference Type DERIVED
PMID: 29076028 (View on PubMed)

Other Identifiers

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2013-004937-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1346.1

Identifier Type: -

Identifier Source: org_study_id

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