Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers

NCT02182284 | Completed Phase 1

• 1 other identifier: 1220.10
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to establish the relative bioavailability of a new soft gelatin capsule (SGC) formulation of BI 201335 NA compared to the current solution formulation (powder in bottle, PIB) for two doses (40 mg, 240 mg) in a parallel, two-way cross-over study design.

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)

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

Secondary Outcomes (11)

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

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

• 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)

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

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

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

• CL/F (apparent clearance of the analyte in the plasma after oral administration)

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

• λz (terminal elimination rate constant in plasma)

  Before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours after administration of study drug

Study Arms (2)

BI 201335 NA - low dose

EXPERIMENTAL

Drug: low dose BI 201335 NA soft gelatine capsule (SGC); Drug: low dose BI 201335 NA powder in bottle (PIB)

BI 201335 NA - high dose

EXPERIMENTAL

Drug: high dose BI 201335 NA soft gelatine capsule (SGC); Drug: high dose BI 201335 NA powder in bottle (PIB)

Interventions

low dose BI 201335 NA soft gelatine capsule (SGC) DRUG

BI 201335 NA - low dose

high dose BI 201335 NA soft gelatine capsule (SGC) DRUG

BI 201335 NA - high dose

low dose BI 201335 NA powder in bottle (PIB) DRUG

BI 201335 NA - low dose

high dose BI 201335 NA powder in bottle (PIB) DRUG

BI 201335 NA - high dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
• Age ≥18 and Age ≤50 years
• Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

You may not qualify if:

• Any finding from the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance, as assessed by the investigator
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Concomitant drugs that in the opinion of the investigator (in consultation with the BI medical monitor or pharmacokinetics), would have interfered with the adsorption, distribution or metabolism of BI 201335
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc (corrected QT interval) interval within 30 days prior to screening until trial completion
• Use of any investigational drug within 30 days prior to enrolment; or the planned usage of any investigational drug during the course of the current study
• Smoking (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• Inability to abstain from alcohol from Day -14 to day 22
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
• Excessive physical activities (within one week prior to administration or during the trial)
• Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgement of the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: January 1, 2008
• Primary Completion: February 1, 2008
• Last Updated: July 18, 2014

Record last verified: 2014-07