Effect of Multiple Dosing With BI 201335 on the Pharmacokinetics of Darunavir Co-administered With Ritonavir in Healthy Male and Female Volunteers

NCT ID: NCT01374802

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30

Brief Summary

The objective of the current study is to investigate the effect of multiple oral daily doses of BI 201335 on the steady-state pharmacokinetics of darunavir co-administered with ritonavir.

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BI 201335

capsule for oral administration

Group Type: EXPERIMENTAL

BI 201335

Intervention Type: DRUG

Darunavir 400 mg

tablet for oral administration

Group Type: EXPERIMENTAL

Darunavir

Intervention Type: DRUG

400 mg tablet for oral administration

Ritonavir 100 mg

tablet for oral administration

Group Type: EXPERIMENTAL

Ritonavir

Intervention Type: DRUG

tablet for oral administration

Interventions

Darunavir

400 mg tablet for oral administration

Intervention Type: DRUG

Ritonavir

tablet for oral administration

Intervention Type: DRUG

BI 201335

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male and female subjects according to the following criteria: medical history, physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram (ECG), clinical laboratory tests

2. Age 18 to 55 years (incl.)

3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.) and weight greater than 50 kg

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 blood pressure (BP), pulse rate (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. History of photosensitivity or recurrent rash.

5. Surgery of the gastrointestinal tract (except appendectomy)

6. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders

7. History of relevant orthostatic hypotension, fainting spells or blackouts.

8. Chronic or relevant acute infections

9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

10. Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial

11. Participation in another trial with an investigational drug within two months prior to administration or during the trial

12. Smoker (more than 10 cigarettes)

13. Inability to refrain from smoking on trial days

14. Alcohol abuse (more than 30 g/day)

15. Drug abuse

16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

17. ALT outside the normal range or any other laboratory value outside the reference range that is of clinical relevance

18. Inability to comply with dietary regimen of trial site

19. The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

20. Positive serology tests for Human immunodeficiency virus (HIV) and hepatitis B / C virus

21. Vulnerable subjects (e.g. persons kept in detention)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1220.49.1 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2011-000505-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1220.49

Identifier Type: -

Identifier Source: org_study_id