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

NCT02256709 | Completed Phase 1

• 1 other identifier: 1214.1
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Number of patients with changes in vital signs

  blood pressure, pulse rate, respiratory rate, body temperature

  baseline, up to 8 days after drug administration

• Number of patients with changes in electrocardiogram (ECG)

  baseline, up to 8 days after drug administration

• Number of patients with changes in safety laboratory parameters

  baseline, up to 8 days after drug administration

• Number of patients with adverse events

  baseline, up to 8 days after drug administration

• Global tolerability assessment by the investigator on a verbal rating scale

  up to 8 days after drug administration

Secondary Outcomes (12)

• Cmax (maximum concentration of the analyte in plasma)

  up to 32 hours after drug administration

• tmax (time from dosing to maximum concentration)

  up to 32 hours after drug administration

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

  up to 32 hours after drug administration

• %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)

  up to 32 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 32 hours after drug administration

Study Arms (8)

single rising dose BIBP 5371 CL

EXPERIMENTAL

Drug: BIBP 5371 CL tablet

BIBP 5371 CL tablet high dose

EXPERIMENTAL

to be compared with same daily dose level from single rising dose arm

Drug: BIBP 5371 CL tablet high dose

BIBP 5371 CL tablet low dose

EXPERIMENTAL

to be compared with same daily dose level from single rising dose arm

Drug: BIBP 5371 CL tablet low dose

Placebo drinking solution

PLACEBO COMPARATOR

Drug: Placebo drinking solution

BIBP 5371 CL drinking solution

EXPERIMENTAL

Drug: BIBP 5371 CL solution

BIBP 5371 CL tablet high dose with food

EXPERIMENTAL

Other: High fat, high caloric breakfast; Drug: BIBP 5371 CL tablet high dose

BIBP 5371 CL tablet low dose with food

EXPERIMENTAL

Other: High fat, high caloric breakfast; Drug: BIBP 5371 CL tablet low dose

Placebo tablet

PLACEBO COMPARATOR

Drug: Placebo tablet

Interventions

BIBP 5371 CL tablet DRUG

single rising daily doses

single rising dose BIBP 5371 CL

BIBP 5371 CL solution DRUG

BIBP 5371 CL drinking solution

High fat, high caloric breakfast OTHER

BIBP 5371 CL tablet high dose with food; BIBP 5371 CL tablet low dose with food

Placebo tablet DRUG

Placebo tablet

BIBP 5371 CL tablet high dose DRUG

BIBP 5371 CL tablet high dose; BIBP 5371 CL tablet high dose with food

Placebo drinking solution DRUG

Placebo drinking solution

BIBP 5371 CL tablet low dose DRUG

BIBP 5371 CL tablet low dose; BIBP 5371 CL tablet low dose with food

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tablets; Solutions

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: April 1, 2004
• Primary Completion: August 1, 2004
• Last Updated: October 6, 2014

Record last verified: 2014-10