Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BILR 355 - Treatment D (current tablet formulation); Drug: BILR 355 - Treatment A (current tablet formulation); Drug: Ritonavir; Drug: BILR 355 - Treatment C (new capsule formulation); Drug: BILR 355 - Treatment B (new tablet formulation); Drug: BILR 355 - Treatment E (new capsule formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02253940

1188.33

Details and patient eligibility

About

Study to determine the single dose, relative BA of new SDS-containing formulations of BILR 355 (150 mg and 200 mg capsules and 150 mg tablet), compared to the current SDS tablet formulation (50 mg tablet)

Enrollment: 40 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy HIV negative adult male volunteers
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

Exclusion criteria

1. 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 was deemed relevant to the trial as judged by the investigator
7. Intake of drugs with a long half-life (>24 hours) within at least one month prior to study drug administration and 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
9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
10. Current smoker
11. Alcohol abuse (more than 60 g/day)
12. Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
13. Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
14. Excessive physical activities (within one week prior to study drug administration or during the trial)
15. Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator
16. Inability to comply with dietary regimen required by the protocol
17. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Dose Group 1 - low dose

Experimental group

Description:

Treatment sequences ABC / CAB / BCA

Treatment:

Drug: Ritonavir

Drug: BILR 355 - Treatment C (new capsule formulation)

Drug: BILR 355 - Treatment B (new tablet formulation)

Drug: BILR 355 - Treatment A (current tablet formulation)

Dose Group 2 - high dose

Experimental group

Description:

Treatment sequences DE / ED

Treatment:

Drug: BILR 355 - Treatment D (current tablet formulation)

Drug: Ritonavir

Drug: BILR 355 - Treatment E (new capsule formulation)