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Safety, Tolerability and Pharmacokinetics of Oral BIBP 5371 CL in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02256709
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBP 5371 CL tablet Drug: BIBP 5371 CL solution Other: High fat, high caloric breakfast Drug: Placebo tablet Drug: BIBP 5371 CL tablet high dose Drug: Placebo drinking solution Drug: BIBP 5371 CL tablet low dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect
Study Start Date : April 2004
Actual Primary Completion Date : August 2004

Arm Intervention/treatment
Experimental: single rising dose BIBP 5371 CL Drug: BIBP 5371 CL tablet
single rising daily doses

Experimental: BIBP 5371 CL tablet high dose
to be compared with same daily dose level from single rising dose arm
Drug: BIBP 5371 CL tablet high dose
Experimental: BIBP 5371 CL tablet low dose
to be compared with same daily dose level from single rising dose arm
Drug: BIBP 5371 CL tablet low dose
Placebo Comparator: Placebo drinking solution Drug: Placebo drinking solution
Experimental: BIBP 5371 CL drinking solution Drug: BIBP 5371 CL solution
Experimental: BIBP 5371 CL tablet high dose with food Other: High fat, high caloric breakfast
Drug: BIBP 5371 CL tablet high dose
Experimental: BIBP 5371 CL tablet low dose with food Other: High fat, high caloric breakfast
Drug: BIBP 5371 CL tablet low dose
Placebo Comparator: Placebo tablet Drug: Placebo tablet



Primary Outcome Measures :
  1. Number of patients with changes in vital signs [ Time Frame: baseline, up to 8 days after drug administration ]
    blood pressure, pulse rate, respiratory rate, body temperature

  2. Number of patients with changes in electrocardiogram (ECG) [ Time Frame: baseline, up to 8 days after drug administration ]
  3. Number of patients with changes in safety laboratory parameters [ Time Frame: baseline, up to 8 days after drug administration ]
  4. Number of patients with adverse events [ Time Frame: baseline, up to 8 days after drug administration ]
  5. Global tolerability assessment by the investigator on a verbal rating scale [ Time Frame: up to 8 days after drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 32 hours after drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: up to 32 hours after drug administration ]
  3. AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 32 hours after drug administration ]
  4. %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 32 hours after drug administration ]
  5. λz (terminal rate constant in plasma) [ Time Frame: up to 32 hours after drug administration ]
  6. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 32 hours after drug administration ]
  7. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: up to 32 hours after drug administration ]
  8. CL/F (apparent clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 32 hours after drug administration ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 32 hours after drug administration ]
  10. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 32 hours after drug administration ]
  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 32 hours after drug administration ]
  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 32 hours after drug administration ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female volunteers
  • Age 21 - 50 years
  • Body mass index (BMI) 18.5 - 29.9 kg/m2

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Diseases of the central nervous system or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
  • Use of any drugs which might influence the results of the trial (within 1 week 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)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (> 60 grams/day)
  • Drug abuse
  • Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
  • Excessive physical activities (within the last week before the study)
  • Any laboratory value outside the reference range of clinical relevance

In addition, for female subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation

Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study

  • Inability to maintain this adequate contraception during the whole study period
  • Lactation period

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02256709     History of Changes
Other Study ID Numbers: 1214.1
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pharmaceutical Solutions