Overview

Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Ritonavir
Criteria
Inclusion Criteria:

1. Males who meet the following criteria:

Based upon a complete medical history, including the physical examination, vital signs
(BP, PR), 12-lead ECG, clinical laboratory tests

- No finding deviating from normal (except as noted below) and of clinical
relevance

- No evidence of a clinically relevant concomitant disease

2. Age ≥18 years and <60

3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)

4. Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Current and medically relevant gastrointestinal, hepatic, renal, respiratory,
cardiovascular, metabolic, immunological or hormonal disorders

2. Surgery of gastrointestinal tract (except appendectomy)

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

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

5. Chronic or relevant acute infections

6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant
to the trial as judged by the investigator

7. Intake of drugs with a long half-life (>24 hours) within one month prior to
administration of study drug or during the trial

8. Use of drugs within 10 days prior to administration or during the trial, which might
reasonably influence the results of the trial based on the knowledge at the time of
protocol preparation

9. Participation in another trial with an investigational drug within one month prior to
administration or during the trial

10. Smoker

11. Inability to refrain from smoking on trial days

12. Alcohol abuse (more than 60 g/day)

13. Drug abuse

14. Recent blood donation (more than 100 mL within 4 weeks prior to administration or
during the trial)

15. Excessive physical activities (within 1 week prior to administration or during the
trial)

16. Any laboratory value outside the normal reference range that is of clinical relevance

17. Inability to comply with dietary regimen of study centre

18. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B
surface antigen, hepatitis B core antibody, or hepatitis C antibody positive)

19. HIV-1 infected as defined by a positive HIV ELISA test