Current partner codePEPTIDESDE
NCT03175211·Phase 1·INTERVENTIONAL

Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

Status

Completed

Phase

Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses. The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing

Interventions

Treatment arms and agents.

DRUG

BI 456906

single dose

DRUG

Placebo

single dose

Timeline

From registration to results.

  1. First posted

    Jun 5, 2017

  2. Study start

    Jun 30, 2017

  3. Primary completion

    Feb 19, 2018

  4. Study completion

    Feb 19, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jul 16, 2018

Outcomes

What the study measures.

Primary outcomes

[N (%)] of subjects with drug-related adverse events.

Time frame · Up to 672 hours

Secondary outcomes

AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)

Time frame · up to 168 hours

Cmax (maximum measured concentration of the analyte in plasma)

Time frame · up to 672 hours

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
MALE
Healthy volunteers
Yes

Inclusion criteria * Healthy male according to the assessment of the Investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests * Age of 18 to 45 years (incl.) * Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.) * Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria * Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged 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 * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation) * Further exclusion criteria apply

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Humanpharmakologisches Zentrum Biberach

Biberach, Germany

Related trials

More studies on Survodutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.