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

Phase I Sequential Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose (225 Mg-450 mg) Oral Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253927

Enrollment

Registered

2014-10-01

Start date

2006-05-31

Completion date

Unknown

Last updated

2014-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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)

Interventions

DRUGBILR 355 - D1

DRUGBILR 355 - D2

DRUGBILR 355 - D3

DRUGBILR 355 - D4

DRUGRitonavir

OTHERhigh fat breakfast

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

1. Males or females who met the inclusion/

Exclusion criteria

, females who are not pregnant nor nursing, and who agreed to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives) 2. Healthy HIV negative adult volunteers 3. Age ≥18 and ≤60 years 4. BMI ≥18.5 and BMI ≤29.9 kg/m2 5. 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

Design outcomes

Primary

Measure	Time frame
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
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
t½ (Terminal half-life of the analyte in plasma)	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

Secondary

Measure	Time frame
Number of patients with adverse events	up to 10 days after last dose administration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026