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Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02182076
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120 soft gelatine capsule with food effect (BA) in healthy subjects respectively.

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBF 1120 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics/Bioavailability of a Single Dose of 150 mg BIBF 1120 Administered as Soft Gelatine Capsules With and Without Food to Healthy Male Volunteers in an Open, Randomised, Intra-individual Crossover Comparison Design
Study Start Date : October 2005
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: fasted administration of BIBF 1120
150 mg of BIBF 1120 ES soft gelatine capsules in fasting state
Drug: BIBF 1120
150 mg of BIBF 1120 ES soft gelatine capsules

Experimental: fed administration of BIBF 1120
three 50 mg BIBF 1120 soft gelatine capsule immediately after a high fat, high caloric meal
Drug: BIBF 1120
150 mg of BIBF 1120 ES soft gelatine capsules




Primary Outcome Measures :
  1. AUC0-∞ (area under the concentration-time curve in plasma over time from zero time extrapolated to infinity) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  2. Cmax (maximum observed concentration in plasma) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]

Secondary Outcome Measures :
  1. tmax (time from dosing to reach Cmax) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  2. t1/2 (terminal half-life in plasma) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  3. MRTpo (mean residence time in the body) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  4. CL/F (apparent clearance in plasma following extravascular administration) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  5. Vz/F (apparent volume of distribution during the terminal phase following extravascular administration) [ Time Frame: Pre-dose and 15, 30, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 33, 48 hours after each administration of study drug ]
  6. Incidence and intensity of adverse events [ Time Frame: up to 14 days ]
  7. Changes from baseline in vital signs (systolic and diastolic blood pressure, Pulse rate) [ Time Frame: up to 14 days ]
  8. Changes from baseline in laboratory tests [ Time Frame: up to 14 days ]
  9. Assessment of global tolerability on a 4-point scale [ Time Frame: Day 3 of each treatment period ]
  10. Changes from baseline in 12-lead electrocardiogram [ Time Frame: up to 14 days ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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 orthostatic hypotension, fainting spells and blackouts
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) 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 10 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 within 1 month prior to administration or during the trial
  • Excessive physical activities within 5 days prior to administration or during the trial
  • Any laboratory value outside the clinically accepted reference range
  • Female gender
  • Male subjects must agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than 3 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, hormonal contraceptive since at least two months and diaphragm with spermicide

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182076    
Other Study ID Numbers: 1199.17
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action