Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 671800; Drug: Placebo

• Registration Number: NCT01215773
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-29
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2010-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 671800 HEA medium dose	BI 671800	Tablet, oral administration with 240 mL of water for each treatment
BI 671800 HEA high dose	BI 671800	2 Tablets, oral administration with 240 mL of water for each treatment
Placebo	Placebo	Matching to HEA 200 mg tablets, oral administration

Primary Outcome Measures

Name	Time	Method
Vital signs (pulse rate (PR))	12 weeks
Adverse events	12 weeks
Clinical laboratory test (clinical chemistry)	12 weeks
Clinical laboratory test (urinalysis)	12 weeks
Physical examination	12 weeks
Vital signs (blood pressure (BP))	12 weeks
12-lead ECG (electrocardiogram)	12 weeks
Clinical laboratory test (haematology)	12 weeks
Assessment of tolerability by investigator	12 weeks

Secondary Outcome Measures

Name	Time	Method
accumulation ratios RA,Cmax	up to day 12 post treatment
Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)	up to day 12 post treatment
Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)	up to day 12 post treatment
AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)	up to day 12 post treatment
λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)	up to day 12 post treatment
t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)	up to day 12 post treatment
Cmax (maximum plasma concentration of BI 671800 or BI 600957)	up to day 12 post treatment
tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)	up to day 12 post treatment
AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)	up to day 12 post treatment
AUC0-tz (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing to time tz of last quantifiable concentration)	up to day 12 post treatment
AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)	up to day 12 post treatment
tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)	up to day 12 post treatment
MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)	up to day 12 post treatment
CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)	up to day 12 post treatment
Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)	up to day 12 post treatment
RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)	up to day 12 post treatment
RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)	up to day 12 post treatment
accumulation ratios RA,AUC	up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 671800	up to day 12 post treatment
peak-trough fluctuation (PTF) of BI 600957	up to day 12 post treatment
linearity index (LI) of BI 671800 in plasma	up to day 12 post treatment

Trial Locations

Locations (1)

1268.59.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany