Single Rising Dose Study of BI 690517 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 690517

• Registration Number: NCT02891148
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-01
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Study Start: 2016-09-29
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 690517	BI 690517	-

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events.	From the first drug administration until end of the trial, up to 14 days	The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs).

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)	Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.	Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
Maximum measured concentration of the BI-690517 in plasma (Cmax)	PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.	Maximum measured concentration of the BI-690517 in plasma (Cmax).

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany