Effects on the Airway Lumen of Talsaclidine in Combination With Propranolol in Comparison to the Effects of the Monosubstances in Healthy Elderly Male Volunteers

NCT02264093 | Completed Phase 1

• 1 other identifier: 506.114
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the effects on airway lumen of talsaclidine in combination with propranolol and of talsaclidine and propranolol given as monosubstances

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Airway resistance (Raw)

  Up to 8 hours after drug administration

• Specific conductance (SGaw)

  Up to 8 hours after drug administration

• Forced expiratory volume in 1 sec (FEV1)

  Up to 8 hours after drug administration

Secondary Outcomes (6)

• Number of participants with clinically significant findings in vital signs

  Up to 8 days after last drug administration

• Number of participants with clinically significant findings in laboratory tests

  Up to 8 days after last drug administration

• Number of participants with adverse events

  Up to 8 days after last drug administration

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

  Up to 12 hours after drug administration

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

  Up to 12 hours after drug administration

Study Arms (3)

Talsaclidine with Propranol

EXPERIMENTAL

Drug: Propranolol; Drug: Talsaclidine

Propranolol

ACTIVE COMPARATOR

Drug: Propranolol

Talsaclidine

ACTIVE COMPARATOR

Drug: Talsaclidine

Interventions

Propranolol DRUG

Propranolol; Talsaclidine with Propranol

Talsaclidine DRUG

Talsaclidine; Talsaclidine with Propranol

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants in the study should be healthy males, range from 50 to 65 years of age and be within +- 20% of their normal weight (Broca-Index).

You may not qualify if:

• Volunteers will be excluded from the study if the result of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from the normal clinical values
• Volunteers with blood pressure lower than 120/80 mm Hg or pulse rate below 60 beats/min
• Volunteers whose blood pressure dropped below 100/60 mm Hg in the pre-test within 80 mg propranolol
• Volunteers with Raw-values higher than their predicted normal upper limit
• Volunteers with known gastrointestinal, hepatic , renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Volunteers with disease 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
• 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 at least one month or less than 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 trial during the week prior the start of the study
• Volunteers who have participated in another study with an investigational drug within the last 2 month preceding this study
• Volunteers who are unable to refrain from smoking on the study days
• Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
• Volunteers who drink more than 40 g of alcohol per day

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Propranolol; talsaclidine fumarate

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 15, 2014
• Study Start: November 1, 1999
• Primary Completion: February 1, 2000
• Last Updated: October 15, 2014

Record last verified: 2014-10