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.
NCT ID: NCT01215773
Last Updated: 2013-11-01
Study Results
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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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 671800 HEA medium dose
Tablet, oral administration with 240 mL of water for each treatment
BI 671800
Medium dose oral administration
BI 671800 HEA high dose
2 Tablets, oral administration with 240 mL of water for each treatment
BI 671800
High dose oral administration
Placebo
Matching to HEA 200 mg tablets, oral administration
Placebo
Matching to HEA 200 mg tablet, oral administration
Interventions
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Placebo
Matching to HEA 200 mg tablet, oral administration
BI 671800
High dose oral administration
BI 671800
Medium dose oral administration
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
50 Years
ALL
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1268.59.1 Boehringer Ingelheim Investigational Site
Ingelheim, , Germany
Countries
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Other Identifiers
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2009-016369-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1268.59
Identifier Type: -
Identifier Source: org_study_id