Bioavailability of Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Solution Formulation in Healthy Volunteers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02182284 |
Recruitment Status :
Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
|
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: low dose BI 201335 NA soft gelatine capsule (SGC) Drug: high dose BI 201335 NA soft gelatine capsule (SGC) Drug: low dose BI 201335 NA powder in bottle (PIB) Drug: high dose BI 201335 NA powder in bottle (PIB) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Randomized, Crossover Relative Bioavailability Study of a New Soft Gelatin Capsule Formulation of BI 201335 NA Compared to the Current Solution Formulation (Powder in Bottle (PIB), After Single Dose Oral Administration in Healthy Volunteers |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | February 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: BI 201335 NA - low dose |
Drug: low dose BI 201335 NA soft gelatine capsule (SGC) Drug: low dose BI 201335 NA powder in bottle (PIB) |
Experimental: BI 201335 NA - high dose |
Drug: high dose BI 201335 NA soft gelatine capsule (SGC) Drug: high dose BI 201335 NA powder in bottle (PIB) |
Primary Outcome Measures :
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: 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) [ Time Frame: 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 Outcome Measures :
- tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]
- MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: 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 ]
- Vz/F (apparent volume of distribution during the terminal phase λz following an oral dose) [ Time Frame: 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 ]
- C24 (measured concentration of the analyte in plasma 24 hours after oral administration) [ Time Frame: 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 ]
- Number of patients with clinically significant changes in vital signs [ Time Frame: Baseline, days 1-6 of each treatment period and day 22 ]
- Number of patients with abnormal changes in laboratory parameters [ Time Frame: Baseline, days 1 and 3-6 of each treatment period and day 22 ]
- Number of patients with adverse events [ Time Frame: up to 29 days ]
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
- Infected with hepatitis A, hepatitis B or hepatitis C viruses (defined as either being hepatitis A antibody positive, hepatitis B surface antigen or HBV DNA positive, or hepatitis C antibody positive)
- Positive ELISA for HIV-1 (Human immunodeficiency virus) or HIV-2
-
For female subjects:
- Pregnancy or planning to become pregnant within 2 months of study completion
- Positive pregnancy test
- No adequate contraception, e.g. sterilisation, IUD (intrauterine device), have not been using a barrier method of contraception for at least 3 months prior to participation in the study
- Are not willing or are unable to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and up to 2 months after completion/termination of the trial
- Lactation period
No Contacts or Locations Provided
Additional Information:
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT02182284 History of Changes |
Other Study ID Numbers: |
1220.10 |
First Posted: | July 8, 2014 Key Record Dates |
Last Update Posted: | July 18, 2014 |
Last Verified: | July 2014 |