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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim

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