Safety and Tolerability Study of BIBF 1120 as Intravenous Infusion and Absolute Bioavailability of BIBF 1120 as Soft Gelatine Capsule in Healthy Subjects

NCT02182258 | Completed Phase 1

• 1 other identifier: 1199.75
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial was to assess the safety and tolerability of BIBF 1120 administered as intravenous (iv) infusions of 1, 3, 10, and 20 mg, and to assess the absolute bioavailability of orally administered 100 mg BIBF 1120 as soft gelatine capsules. A secondary objective was the exploration of the pharmacokinetic (PK) of BIBF 1120 after single iv dosing, including dose proportionality.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  Up to 48 hours after drug administration

• 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 (AUC0-tz)

  Up to 48 hours after drug administration

Secondary Outcomes (21)

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

  Up to 48 hours after drug administration

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

  Up to 48 hours after drug administration

• %AUCtz-∞ (calculated from AUC0-∞ and AUC0-tz )

  Up to 48 hours after drug administration

• Terminal rate constant in plasma (λz)

  Up to 48 hours after drug administration

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

  Up to 48 hours after drug administration

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo ampoule

BIBF 1120 intravenous

ACTIVE COMPARATOR

Drug: BIBF 1120 intravenous solution

BIBF 1120 capsule

EXPERIMENTAL

Drug: BIBF 1120 soft gelatine capsule

Interventions

BIBF 1120 soft gelatine capsule DRUG

BIBF 1120 capsule

BIBF 1120 intravenous solution DRUG

BIBF 1120 intravenous

Placebo ampoule DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Any finding from medical examination (including blood pressure, pulse rate, ECG) deviating from normal and of clinical relevance
• History of or current gastrointestinal, hepatic (including Gilbert's syndrome and history of bilirubin increases) renal, respiratory, cardiovascular, metabolic, immunological or 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 haematologic disease or cerebral bleeding (e.g. after a car accident) or commotio cerebri
• Intake of drugs with a long half-life (\>24 h) within 1 month prior to administration or during the trial
• 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 the trial
• Smoker (\>10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
• Alcohol abuse (\>30 g/day)
• Drug abuse
• Blood donation (\>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: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Last Updated: July 18, 2014

Record last verified: 2014-07