Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers

NCT02184312 | Completed Phase 1

• 1 other identifier: 1100.1517
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended release tablet

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  up to 144 hours after drug administration

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

  up to 144 hours after drug administration

Secondary Outcomes (13)

• 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 144 hours after drug administration

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

  up to 144 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 144 hours after drug administration

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

  up to 144 hours after drug administration

• MRTpo (mean residence time of the analyte in the body after po administration)

  up to 144 hours after drug administration

Study Arms (4)

Nevirapine XR low dose

EXPERIMENTAL

Drug: Nevirapine XR low dose

Nevirapine XR medium dose

EXPERIMENTAL

Drug: Nevirapine XR medium dose

Nevirapine XR high dose

ACTIVE COMPARATOR

Drug: Nevirapine XR high dose

Nevirapine (VIRAMUNE®)

ACTIVE COMPARATOR

commercial product

Drug: Nevirapine (VIRAMUNE®)

Interventions

Nevirapine XR low dose DRUG

Nevirapine XR low dose

Nevirapine XR medium dose DRUG

Nevirapine XR medium dose

Nevirapine XR high dose DRUG

Nevirapine XR high dose

Nevirapine (VIRAMUNE®) DRUG

Nevirapine (VIRAMUNE®)

Eligibility Criteria

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

You may qualify if:

• Healthy males according to the following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory; values within normal ranges or deviating from normal without clinical relevance as considered by the investigator
• Values of Liver Function Test (LFT) have to be within normal ranges
• Age ≥18 and Age ≤60 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the post study medical examination. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least two month)
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders of clinical relevance
• Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
• 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Participation to trial BI 1100.1485 or any other intake of Nevirapine
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Nevirapine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 9, 2014
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Last Updated: July 14, 2014

Record last verified: 2014-07