Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects

NCT ID: NCT02256826

Last Updated: 2014-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

Brief Summary

To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Group Type: EXPERIMENTAL

BILR 355 BS

Intervention Type: DRUG

Ritonavir (RTV)

Intervention Type: DRUG

NORVIR®

Kaletra®

Intervention Type: DRUG

(lopinavir (LPV) and ritonavir (RTV))

Group B

Group Type: EXPERIMENTAL

BILR 355 BS

Intervention Type: DRUG

Ritonavir (RTV)

Intervention Type: DRUG

NORVIR®

Interventions

BILR 355 BS

Intervention Type: DRUG

Ritonavir (RTV)

NORVIR®

Intervention Type: DRUG

Kaletra®

(lopinavir (LPV) and ritonavir (RTV))

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

2. Age ≥18 and <60 years

3. BMI ≥18.5 and BMI ≤29.9 kg/m2

4. Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations

1. Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

2. Surgery of gastrointestinal tract (except appendectomy)

3. Currently active (symptomatic within the last 30 days) 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. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator

6. Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)

7. 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 (review with clinical monitor if questionable)

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

9. Current smoker

10. Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)

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

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

13. Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator

14. Inability to comply with dietary regimen required by the protocol

15. Chronic or relevant acute infections

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

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

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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1188.8

Identifier Type: -

Identifier Source: org_study_id