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.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 671800; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215773

2009-016369-27 (EudraCT Number)

1268.59

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

BI 671800 HEA medium dose

Experimental group

Description:

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

Treatment:

Drug: BI 671800

Drug: BI 671800

BI 671800 HEA high dose

Experimental group

Description:

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

Treatment:

Drug: BI 671800

Drug: BI 671800

Placebo

Placebo Comparator group

Description:

Matching to HEA 200 mg tablets, oral administration

Treatment:

Drug: Placebo