Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

NCT01704846 | Completed Phase 1 Results

• 1 other identifier: 1220.53
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

• Maximum Measured Concentration (Cmax)

  Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

Secondary Outcomes (5)

• Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

• Time From Dosing to the Maximum Measured Concentration (Tmax)

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

• Terminal Rate Constant (λz)

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

• Terminal Half-life (t1/2)

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

• Mean Residence Time (MRTpo)

  3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration

Study Arms (2)

Treatment sequence 1

EXPERIMENTAL

Test - Reference - Reference - Test

Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule

Treatment sequence 2

EXPERIMENTAL

Reference - Test - Test - Reference

Drug: BI 201335 NA 120 mg capsule; Drug: BI 201335 NA 40 mg capsule

Interventions

BI 201335 NA 120 mg capsule DRUG

1capsule of BI 201335 NA 120 mg capsule

Treatment sequence 2

BI 201335 NA 40 mg capsule DRUG

3 capsules of BI 201335 NA 40 mg capsule

Treatment sequence 1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers without any clinical significant findings and complications
• Age: 20 - 45 years
• BMI: 18.5 - 25.0 kg/m2
• Signed informed consent

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance.
• Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
• History of jaundice
• Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement.
• 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 (pharmacokinetic) of the trial within at least 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.
• Smoking (\>10 cigarettes or \>3 cigars or \>3 pipes/day).
• Inability to refrain from smoking during the trial.
• Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 mL\] of sake).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1220.53.08101 Boehringer Ingelheim Investigational Site

Sumida-ku,Tokyo, Japan

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 31, 2015
• Results First Posted: July 31, 2015

Record last verified: 2015-07

Locations

JP (1)