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

NCT ID: NCT02253914

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29

Brief Summary

Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BILR 355 BS, solution

escalating doses

Group Type: EXPERIMENTAL

BILR 355 BS, solution

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

BILR 355 BS, tablet

escalating doses

Group Type: EXPERIMENTAL

BILR 355 BS, tablet

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

BILR 355 BS, solution

Intervention Type: DRUG

BILR 355 BS, tablet

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1188.2

Identifier Type: -

Identifier Source: org_study_id