Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers

NCT02253940 | Completed Phase 1

• 1 other identifier: 1188.33
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-inf (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 96 hours after drug administration

• Cmax (maximum measured concentration of analyte in plasma)

  up to 96 hours after drug administration

Secondary Outcomes (6)

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 96 hours after drug administration

• tmax (time from dosing to the maximum concentration of the analyte in plasma)

  up to 96 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 96 hours after drug administration

• CL/F (apparent clearance of the analyte in the plasma after extravascular administration)

  up to 96 hours after drug administration

• Number of subjects with adverse events

  up to 12 days following last drug administration

Study Arms (2)

Dose Group 1 - low dose

EXPERIMENTAL

Treatment sequences ABC / CAB / BCA

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

Dose Group 2 - high dose

EXPERIMENTAL

Treatment sequences DE / ED

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

Interventions

BILR 355 - Treatment A (current tablet formulation) DRUG

Dose Group 1 - low dose

BILR 355 - Treatment B (new tablet formulation) DRUG

Dose Group 1 - low dose

BILR 355 - Treatment C (new capsule formulation) DRUG

Dose Group 1 - low dose

BILR 355 - Treatment D (current tablet formulation) DRUG

Dose Group 2 - high dose

BILR 355 - Treatment E (new capsule formulation) DRUG

Dose Group 2 - high dose

Ritonavir DRUG

Dose Group 1 - low dose; Dose Group 2 - high dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy HIV negative adult male volunteers
• Age ≥18 and ≤60 years
• BMI ≥18.5 and BMI ≤29.9 kg/m2
• 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

You may not qualify if:

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\>24 hours) within at least one month prior to study drug administration and during the trial
• Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Current smoker
• Alcohol abuse (more than 60 g/day)
• Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
• Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
• Excessive physical activities (within one week prior to study drug administration or during the trial)
• Any laboratory value outside the reference range that was of clinical relevance at screening, according to the judgment of the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Dosage Forms; Ritonavir

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: October 1, 2006
• Primary Completion: December 1, 2006
• Last Updated: October 1, 2014

Record last verified: 2014-09