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

HIV Infections Clinical Trial

Official title:

Effect of Multiple Dosing With 240 mg QD BI 201335 on the Steady-state Pharmacokinetics of 800 mg QD Darunavir Coadministered With 100 mg QD Ritonavir (DRV/r) in Healthy Male and Female Volunteers (an Open-label, Multiple-dose, Single Group, Single Fixed Sequence Phase I Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374802
• Other study ID #: 1220.49
• Secondary ID: 2011-000505-41
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2011
• Last updated: July 3, 2015
• Start date: June 2011

Study information

• Verified date: July 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Darunavir
400 mg tablet for oral administration
• Ritonavir
tablet for oral administration
• BI 201335

Locations

Country	Name	City	State
Germany	1220.49.1 Boehringer Ingelheim Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt,ss of Darunavir	area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval t of darunavir.; The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	No
Primary	Ct,ss of Darunavir	concentration of the analyte in plasma at steady-state after a uniform dosing interval t=24h of darunavir	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	No
Primary	Cmax,ss of Darunavir	maximum measured concentration of the analyte in plasma at steady-state	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	No
Secondary	Tmax,ss of Darunavir	time from last dosing to maximum concentration of the analyte in plasma at steady state	0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)	No

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