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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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BI 671800 HEA medium dose

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

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

Medium dose oral administration

BI 671800 HEA high dose

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

Group Type EXPERIMENTAL

BI 671800

Intervention Type DRUG

High dose oral administration

Placebo

Matching to HEA 200 mg tablets, oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching to HEA 200 mg tablet, oral administration

Interventions

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Placebo

Matching to HEA 200 mg tablet, oral administration

Intervention Type DRUG

BI 671800

High dose oral administration

Intervention Type DRUG

BI 671800

Medium dose oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Age 21 to 50 years (incl.)
3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
8. 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
9. Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
10. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes daily)
11. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males) or positive alcohol test
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)
14. 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.
15. Inability to comply with dietary regimen of trial site
16. Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval within 10 days prior to administration or during the trial, and CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan, acenocoumarol within 1 month or six half lives (whichever is greater).
17. Repeated demonstration of a QTc interval \>450 ms, PR interval \>230 ms or a QRS interval \>120 ms; history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)

For female subjects of childbearing potential only:
18. Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 2 months after study completion
19. No adequate contraception during the study including three months before first dosing until 2 month after study completion, e.g. not any of the following: implants, injectables, combined hormonal contraceptives, intrauterine device, or surgical sterilisation (including hysterectomy). In addition to this, also a barrier method (e.g. condom) will be required, if the female is not surgically sterilised.
20. Lactation

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes