Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers

NCT02253914 | Completed Phase 1

• 1 other identifier: 1188.2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• AUCτ (area under the concentration time curve of BILR 355 in plasma over one dosing interval at steady state)

  up to day 11

• Cmax (maximum concentration of BILR 355 in plasma)

  up to day 11

• Time for BILR 355 BS to achieve steady state

  up to day 11

• Cmin,ss (trough concentration of BILR 355 BS in plasma at steady state)

  up to day 11

• Incidence of dose limiting toxicity

  up to day 21

Secondary Outcomes (6)

• tmax (time from dosing to the maximum concentration of BILR 355 in plasma)

  up to day 11

• AUCτ (area under the concentration time curve of metabolite 402 in plasma over one dosing interval at steady state)

  up to day 11

• Cmax (maximum concentration of metabolite 402 in plasma)

  up to day 11

• Ae (amount of BILR 355 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)

  up to day 11

• Metabolite BILR 402 Ae (amount of BILR 402 excreted in the urine over the time interval from 0 to the time of the last urine collection interval)

  up to day 11

Study Arms (3)

BILR 355 BS, solution

EXPERIMENTAL

escalating doses

Drug: BILR 355 BS, solution; Drug: Ritonavir

BILR 355 BS, tablet

EXPERIMENTAL

escalating doses

Drug: BILR 355 BS, tablet; Drug: Ritonavir

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BILR 355 BS, solution DRUG

BILR 355 BS, solution

BILR 355 BS, tablet DRUG

BILR 355 BS, tablet

Ritonavir DRUG

BILR 355 BS, solution; BILR 355 BS, tablet

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males who meet the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• No finding deviating from normal (except as noted below) and of clinical relevance
• No evidence of a clinically relevant concomitant disease
• Age ≥18 years and \<60
• BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Current and medically relevant 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 one month prior to administration of study drug or 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 based on the knowledge at the time of protocol preparation
• Participation in another trial with an investigational drug within one month prior to administration or during the trial
• Smoker
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities (within 1 week prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions; Tablets; Ritonavir

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Dosage Forms; 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: February 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: October 1, 2014

Record last verified: 2014-09