Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers

NCT02253953 | Completed Phase 1

• 1 other identifier: 1188.4
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Maximum observed concentration of the analyte in plasma (Cmax)

  up to 120 hours after drug administration

• Time to reach Cmax (tmax)

  up to 120 hours after drug administration

• Area under the concentration-time curve (AUC)

  up to 120 hours after drug administration

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

  up to 120 hours after drug administration

• Total clearance of the analyte in plasma (CL/F)

  up to 120 hours after drug administration

• Total mean residence time (MRTtot)

  up to 120 hours after drug administration

• Apparent volume of distribution (Vz/F)

  up to 120 hours after drug administration

• Renal clearance (CLR)

  up to 72 hours after drug administration

• Urinary excretion (Ae)

  up to 72 hours after drug administration

Secondary Outcomes (1)

• Number of subjects with adverse events

  up to 26 days

Study Arms (10)

D1

EXPERIMENTAL

Drug: BILR 355 BS, D1; Drug: Ritonavir

D2

EXPERIMENTAL

Drug: BILR 355 BS, D2; Drug: Ritonavir

D3

EXPERIMENTAL

Drug: BILR 355 BS, D3; Drug: Ritonavir

D4

EXPERIMENTAL

Drug: BILR 355 BS, D4; Drug: Ritonavir

D5

EXPERIMENTAL

Drug: BILR 355 BS, D5; Drug: Ritonavir

D6

EXPERIMENTAL

Drug: BILR 355 BS, D6; Drug: Ritonavir

D7

EXPERIMENTAL

Drug: BILR 355 BS, D7; Drug: Ritonavir

D8

EXPERIMENTAL

Drug: BILR 355 BS, D8; Drug: Ritonavir

D10

EXPERIMENTAL

Drug: BILR 355 BS, D10; Other: high-fat breakfast; Drug: Ritonavir

Placebo

PLACEBO COMPARATOR

for D3 - D10

Drug: Placebo; Drug: Ritonavir

Interventions

BILR 355 BS, D1 DRUG

D1

BILR 355 BS, D2 DRUG

D2

BILR 355 BS, D3 DRUG

D3

BILR 355 BS, D4 DRUG

D4

BILR 355 BS, D5 DRUG

D5

BILR 355 BS, D6 DRUG

D6

BILR 355 BS, D7 DRUG

D7

BILR 355 BS, D8 DRUG

D8

BILR 355 BS, D10 DRUG

D10

Placebo DRUG

Placebo

high-fat breakfast OTHER

D10

Ritonavir DRUG

D1; D10; D2; D3; D4; D5; D6; D7; D8; Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants in the study should be healthy males
• Age range from 21 to 50 years
• Body mass index (BMI) be within 18.5 to 29.9 kg/m2
• In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is 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 or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the clinically accepted reference range

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 1, 2014
• Study Start: November 1, 2002
• Primary Completion: December 1, 2003
• Last Updated: October 1, 2014

Record last verified: 2014-09