Safety, Tolerability and Pharmacodynamics After Oral Administration of BIIF 1149 BS in Healthy Male Volunteers

NCT02209714 | Completed Phase 1

• 1 other identifier: 1157.4
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to obtain information about the safety and tolerability of BIIF 1149 BS45 (single dose: 40, 65, 100 mg), to determine the pharmacologically active dose (range) by performing a citric acid challenge test and to obtain preliminary pharmacokinetic data.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Number of patients with clinically relevant changes in vital functions (blood pressure, pulse rate)

  up to 8 days after last drug administration

• Number of patients with clinically relevant changes in electrocardiogram (ECG)

  up to 8 days after last drug administration

• Number of patients with clinically relevant changes in laboratory parameters

  up to 8 days after last drug administration

• Number of patients with adverse events

  up to 8 days after last drug administration

Secondary Outcomes (10)

• Maximum drug plasma concentration (Cmax)

  up to 360 hours after drug administration

• Time to reach maximum drug concentration (tmax)

  up to 360 hours after drug administration

• Total area under the plasma drug concentration-time curve (AUC) for several time points

  up to 360 hours after drug administration

• Terminal half-life (t1/2)

  up to 360 hours after drug administration

• Mean residence time (MRT)

  up to 360 hours after drug administration

Study Arms (2)

BIIF 1149 BS

EXPERIMENTAL

Drug: BIIF 1149 BS

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BIIF 1149 BS DRUG

BIIF 1149 BS

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males, based on a complete medical examination
• Age range from 21 to 50 years
• +/- 20 % of their normal weight (Broca-Index)
• Written informed consent

You may not qualify if:

• Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
• Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
• Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
• Volunteers with chronic or relevant acute infections (especially respiratory infections, cough)
• Volunteers with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
• Volunteers who received any other drugs which might influence the results of the study during the week prior to the start of the study
• Volunteers who have participated in another study with an investigational drug within the last 2 months preceding this study
• Volunteers who smoke more than 10 cigarettes (or equivalent) per day
• Volunteers who are not able to refrain from smoking on study days
• Volunteers who drink more than 40 g of alcohol per day
• Volunteers who are dependent on drugs
• Volunteers who are participated in excessive physical activities (e.g. competitive sports) during the last week before the study
• Volunteers who have donated blood (≥ 100 ml) within the last four weeks

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: August 5, 2014
• First Posted: August 6, 2014
• Study Start: November 1, 1999
• Primary Completion: February 1, 2000
• Last Updated: August 6, 2014

Record last verified: 2014-08