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OpenTrials
Completed

NCT Number: NCT02068690

Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1346.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BI 425809 PfOS

Drug

BI 425809 as a powder for an oral solution (PfOS)

Other names: Iclepertin

Placebo PfOS

Drug

Placebo as a powder for an oral solution (PfOS)

BI 425809 tablet

Drug

BI 425809 as a tablet

Other names: Iclepertin

Primary outcomes

  1. Number of Participants With Drug-related Adverse Events (AE)

    Time frame: SRD Part: From the time of first drug administration until the end of study, up to 18 days. BA/FE Part: From the time of first drug administration until the end of the intervention period, up to 18 days for each intervention.

    Number of participants with drug-related Adverse Events (AE). Drug-relatedness was assessed by the investigator.

Secondary outcomes

  1. SRD Part: Maximum Concentration of BI 425809 in Plasma (Cmax)

    Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

    Maximum measured concentration of BI 425809 in plasma (Cmax) in the Single Rising Dose (SRD) part of the trial is reported.

  2. BA/FE Part: Maximum Concentration of BI 425809 in Plasma (Cmax)

    Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

    Maximum measured concentration of BI 425809 in plasma (Cmax) in the bioavailability/food effect (BA/FE) part of the trial is reported.

  3. SRD Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))

    Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

    Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Single Rising Dose (SRD) part of the trial is reported.

  4. BA/FE Part: Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC(0-∞))

    Time frame: 2 hours (h) before drug administration and 15 minutes (m), 30m, 45m, 1h, 1h30m, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h, 120h, 144h, 168h, 192h after drug administration.

    Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC(0-∞)) in the Bioavailability/Food Effect (BA/FE) part of the trial is reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2014
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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