To Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1467335 Following Multiple Dose Administration Over 28 Days

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1467335; Drug: Placebo

• Registration Number: NCT02733627
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1467335 in healthy male and female subjects following oral administration of multiple rising doses over 28 days.

Secondary objectives are the exploration of the pharmacokinetics (PK) and target engagement biomarkers of BI 1467335 after multiple dosing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Study Start: 2016-07-07
• Primary Completion: 2017-07-12
• Study Completion: 2017-07-12
• Status Verified: 2021-05
• Results First Submitted: 2021-05-11
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-06-07
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1467335 15 mg (medium dose)	BI 1467335	-
BI 1467335 10 mg (low dose)	BI 1467335	-
BI 1467335 20 mg (high dose)	BI 1467335	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Investigator Defined Drug-related Adverse Events	From first day of study drug administration until 20 days after last dose of study drug administration, up to 48 days.	Number of subjects with investigator defined drug-related adverse events (AEs) is reported.

Secondary Outcome Measures

Name	Time	Method
Cmax,28	648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h, 672:00 h after first drug administration on Day 1.	Cmax,28 is the maximum measured concentration of BI 1467335 in plasma following administration of the 28th dose.
Cmax	0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.	Cmax is the maximum measured concentration of BI 1467335 in plasma after administration of the first dose.
AUC0-24	0:00 hour (h) (within 30 minutes prior to dosing) and 0:15 h, 0:30 h, 0:45 h, 1:00 h, 1:30 h, 2:00 h, 3:00 h, 4:00 h, 6:00 h, 8:00 h, 10:00 h, 12:00 h and 24:00 h after drug administration on Day 1.	AUC0-24 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the first dose.
AUC0-24,28	648:00 hours (h) (within 30 minutes prior to dosing) and 648:15 h, 648:30 h, 648:45 h, 649:00 h, 649:30 h, 650:00 h, 651:00 h, 652:00 h, 654:00 h, 656:00 h, 658:00 h, 660:00 h and 672:00 h after first drug administration on Day 1.	AUC0-24,28 is the area under the concentration-time curve of BI 1467335 in plasma over the time interval from 0 to 24 hours after administration of the 28th dose.

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany