BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: BI 443651; Drug: Placebo

• Registration Number: NCT02976519
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-25
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-29
• Study Start: 2017-02-15
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2019-11
• Results First Submitted: 2019-11-07
• Results First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 443651	BI 443651	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2	Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)	Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1	Day 1 and Day 7 (Please check the measure description for detailed timeframe)	Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).
Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1	Day 1 and Day 7 (Please check the measure description for detailed timeframe)	Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).

Trial Locations

Locations (5)

The Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom

Lungenärztliche Praxis; 🇩🇪 München-Pasing, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

IKF Pneumologie GmbH & Co. KG; 🇩🇪 Frankfurt, Germany

Celerion Inc; 🇬🇧 Belfast, United Kingdom