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.

NCT01215773 | Completed Phase 1

• 2 other identifiers: 1268.592009-016369-27
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Vital signs (pulse rate (PR))

  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

• Adverse events

  12 weeks

• Assessment of tolerability by investigator

  12 weeks

Secondary Outcomes (21)

• 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

• 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

• 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

Study Arms (3)

BI 671800 HEA medium dose

EXPERIMENTAL

Tablet, oral administration with 240 mL of water for each treatment

Drug: BI 671800

BI 671800 HEA high dose

EXPERIMENTAL

2 Tablets, oral administration with 240 mL of water for each treatment

Drug: BI 671800

Placebo

PLACEBO COMPARATOR

Matching to HEA 200 mg tablets, oral administration

Drug: Placebo

Interventions

Placebo DRUG

Matching to HEA 200 mg tablet, oral administration

Placebo

BI 671800 DRUG

High dose oral administration

BI 671800 HEA high dose

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
• Age 21 to 50 years (incl.)
• Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half life (\>24 h) within one month or less than 10 half-lives of the respective drug prior to first study drug administration
• Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
• Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males) or positive alcohol test
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
• Any laboratory value outside the reference range that is of clinical relevance, especially repeated Alanine transaminase (ALT), Aspartate transaminase (AST), Gamma-glutamyl-transferase (GGT), Alkaline phosphatase (ALP) or total bilirubin above upper limit of normal (ULN) at screening and not resolved before dosing.
• Inability to comply with dietary regimen of trial site

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1268.59.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

BI 671800

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (1)