CompletedNCT01587391Updated Oct 31, 2013

Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

A Phase 1 interventional study of Placebo to BI 163538 XX and BI 163538 XX in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-31.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: Male

Study summary

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range

Conditions studied

Healthy

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy male subjects
overweight or obese

Exclusion criteria

Exclusion criteria:

Any relevant deviation from healthy conditions

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 48 participants (actual)

Study arms

Experimental
BI 163538 XX
1 single dose per subject as oral solution
Drug: BI 163538 XX
Placebo comparator
Placebo to BI 163538 XX
1 single dose per subject as oral solution
Drug: Placebo to BI 163538 XX

Interventions

DrugPlacebo to BI 163538 XX
1 single dose per subject as oral solution
DrugBI 163538 XX
1 single dose per subject as oral solution

What researchers measure

Primary outcomes

Occurrence of adverse events
Time frame: up to 15 days postdose

Secondary outcomes

Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 96 hours postdose
AUC0-∞ (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 96 hours postdose
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: up to 96 hours postdose

Study locations

1 site

1291.1.1 Boehringer Ingelheim Investigational Site
Neuss, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01587391
Lead sponsor: Boehringer Ingelheim
Responsible party: Sponsor
First posted: Apr 30, 2012
Start date: Apr 2012
Primary completion: Oct 2012
Completion: Oct 2012
Last update: Oct 31, 2013

Study contacts

Boehringer Ingelheim

study chair · Boehringer Ingelheim

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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