Safety and Relative Bioavailability of BIBF 1120 Soft Gelatine Capsules Charge 1, BIBF 1120 Soft Gelatine Capsules Charge 2 and BIBF 1120 Drinking Solution in Healthy Male Volunteers

NCT02182193 | Completed Phase 1

• 1 other identifier: 1199.21
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess pharmacokinetics and the relative bioavailability of a single dose of BIBF 1120 soft gelatine capsule charge 1 vs. BIBF 1120 soft gelatine capsule charge 2 vs BIBF 1120 drinking solution in healthy male subjects respectively. To establish an in-vitro-in-vivo correlation (IVIVC) for oral soft gelatine capsules with 150 mg BIBF 1120 in healthy male volunteers (if feasible)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve of the analyte from zero time (pre-dose) extrapolated to infinity (AUC0-∞)

  1 h pre dose and up to 48 h after drug administration

• Individual maximum observed concentrations of the analyte in plasma (Cmax)

  1 h pre dose and up to 48 h after drug administration

Secondary Outcomes (12)

• Area under the plasma concentration-time curve of the analyte over the time interval from time zero (pre-dose) to 24 hours (AUC0-24)

  1 h pre dose and up to 24 h after drug administration

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

  1 h pre dose and up to 48 h after drug administration

• Terminal rate constant in plasma (λz)

  1 h pre dose and up to 48 h after drug administration

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

  1 h pre dose and up to 48 h after drug administration

• Mean residence time of the analyte in the body after oral administration (MRTpo)

  1 h pre dose and up to 48 h after drug administration

Study Arms (3)

BIBF 1120 capsules charge 1

EXPERIMENTAL

Drug: BIBF 1120 capsules charge 1

BIBF 1120 capsules charge 2

EXPERIMENTAL

Drug: BIBF 1120 capsules charge 2

BIBF 1120 drinking solution

ACTIVE COMPARATOR

Drug: BIBF 1120 drinking solution

Interventions

BIBF 1120 capsules charge 1 DRUG

BIBF 1120 capsules charge 1

BIBF 1120 capsules charge 2 DRUG

BIBF 1120 capsules charge 2

BIBF 1120 drinking solution DRUG

BIBF 1120 drinking solution

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥21 and ≤55 years
• Body Mass Index ≥18.5 kg/m2 and ≤29.9 kg/m2

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of relevant orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy or its excipients) which is deemed relevant to the trial as judged by the investigator
• History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
• Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 14 days prior to administration or during the trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (more than 150 mL within 4 weeks prior to administration or during the trial)
• Excessive physical activities within 5 days prior to administration or during the trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON 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: September 1, 2006
• Primary Completion: November 1, 2006
• Last Updated: July 18, 2014

Record last verified: 2014-07