Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

NCT02253927 | Completed Phase 1

• 1 other identifier: 1188.32
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses. A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

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

  up to 120 hours after drug administration

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

  up to 120 hours after drug administration

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

  up to 120 hours after drug administration

• CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

  up to 120 hours after drug administration

• Tmax (Time from dosing to the maximum concentration of the analyte in plasma)

  up to 120 hours after drug administration

• t½ (Terminal half-life of the analyte in plasma)

  up to 120 hours after drug administration

Secondary Outcomes (1)

• Number of patients with adverse events

  up to 10 days after last dose administration

Study Arms (1)

BILR 355 (dose escalation) + Ritonavir

EXPERIMENTAL

escalating dose groups, for food effect evaluation lowest dose group (D1) with high fat meal breakfast after wash-out period

Drug: BILR 355 - D1; Drug: BILR 355 - D2; Drug: BILR 355 - D3; Drug: BILR 355 - D4; Drug: Ritonavir; Other: high fat breakfast

Interventions

BILR 355 - D1 DRUG

BILR 355 (dose escalation) + Ritonavir

BILR 355 - D2 DRUG

BILR 355 (dose escalation) + Ritonavir

BILR 355 - D3 DRUG

BILR 355 (dose escalation) + Ritonavir

BILR 355 - D4 DRUG

BILR 355 (dose escalation) + Ritonavir

Ritonavir DRUG

BILR 355 (dose escalation) + Ritonavir

high fat breakfast OTHER

BILR 355 (dose escalation) + Ritonavir

Eligibility Criteria

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

You may not qualify if:

• Healthy HIV negative adult 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
• 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 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 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)

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

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

Record last verified: 2014-09