Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133482

Enrollment

Registered

2014-05-08

Start date

2014-07-31

Completion date

2014-10-31

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.

Interventions

DRUGPlacebo

placebo solution

DRUGBI 639667

oral solution BI 639667, single rising doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male subjects 2. age of 18 to 50 years 3. body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mmHg, or pulse rate outside the range of 50 to 90 mmHg at screening 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease judged as clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair) 7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Number of subjects with drug-related adverse events	up to 19 days postdose

Secondary

Measure	Time frame
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 120 hours postdose
Cmax (maximum measured concentration of the analyte in plasma)	up to 120 hours postdose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026