NCT02172781

Brief Summary

Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • AUC - Area under the curve of the log-transformed value of salivary secretion after application of randomised treatment

    over the interval from two hours to six hours on study day 19 and 22

Secondary Outcomes (21)

  • Cmax (Peak (maximum) plasma concentration) - Tiotropium

    Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)

  • Cmax,ss (maximum observed concentration of the analyte in plasma at steady state) - Tiotropium

    Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)

  • Tmax (time to reach the peak plasma concentration) - Tiotropium

    Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)

  • Tmax, ss (Time to reach maximum concentration of the analyte in plasma at steady state) - Tiotropium

    Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)

  • Cpre (predose concentration of the analyte in plasma) -Tiotropium

    Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)

  • +16 more secondary outcomes

Study Arms (5)

Ipratropium - unit dose vial

EXPERIMENTAL
Drug: Ipratropium - unit dose vialDrug: Placebo matching ipratropium

Tiotropium - inhalation capsule - low dose

EXPERIMENTAL
Drug: Ipratropium - unit dose vialDrug: Tiotropium - inhalation capsuleDrug: Placebo matching tiotropiumDrug: Placebo matching ipratropium

Placebo matching tiotropium - inhalation capsule

PLACEBO COMPARATOR
Drug: Ipratropium - unit dose vialDrug: Tiotropium - inhalation capsuleDrug: Placebo matching tiotropiumDrug: Placebo matching ipratropium

Placebo matching to ipratropium - unit dose vial

PLACEBO COMPARATOR
Drug: Ipratropium - unit dose vialDrug: Tiotropium - inhalation capsuleDrug: Placebo matching tiotropiumDrug: Placebo matching ipratropium

Tiotropium - inhalation capsule - high dose

EXPERIMENTAL
Drug: Ipratropium - unit dose vialDrug: Tiotropium - inhalation capsuleDrug: Placebo matching ipratropium

Interventions

Ipratropium - unit dose vialDRUG
Ipratropium - unit dose vialPlacebo matching tiotropium - inhalation capsulePlacebo matching to ipratropium - unit dose vialTiotropium - inhalation capsule - high doseTiotropium - inhalation capsule - low dose
Tiotropium - inhalation capsuleDRUG
Placebo matching tiotropium - inhalation capsulePlacebo matching to ipratropium - unit dose vialTiotropium - inhalation capsule - high doseTiotropium - inhalation capsule - low dose
Placebo matching tiotropiumDRUG
Placebo matching tiotropium - inhalation capsulePlacebo matching to ipratropium - unit dose vialTiotropium - inhalation capsule - low dose
Placebo matching ipratropiumDRUG
Ipratropium - unit dose vialPlacebo matching tiotropium - inhalation capsulePlacebo matching to ipratropium - unit dose vialTiotropium - inhalation capsule - high doseTiotropium - inhalation capsule - low dose

Eligibility Criteria

Age40 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants in the study should be healthy males, ranging from 40 to 65 years of age and within ±20% of their normal weight (Broca-Index)
  • Each subject will have his medical history taken and will receive a complete medical examination (including blood pressure and pulse rate measurements) as well as a 12-lead ECG.
  • Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscentia GmbH, FRG). The subjects will fast for 8 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first drug administration.
  • In accordance with Good Clinical Practice (GCP) and local legislation all subjects will have given their written informed consent prior to admission to the study.
  • Normal spirometry as evidenced by a baseline FEV1 ≥ 80% of predicted normal value for age, height and sex. Predicted normal values will be calculated according to European Community of Coal and Steel (ECCS)
  • Ability to perform technically satisfactory pulmonary function tests.

You may not qualify if:

  • Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
  • History of 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 (≥ 24hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study.
  • Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study, among these all non-selective beta blockers, oral beta adrenergics or long-acting beta-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT ®(ipratropium) by oral inhalation and ATROVENT® Nasal Spray.
  • Participation in another trial with an investigational drug (≤ two months prior to administration or during trial).
  • Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
  • Inability to refrain from smoking on trial days.
  • Alcohol abuse (\> 60g/day)
  • Drug abuse
  • Blood donation (≥ 100 ml within four weeks prior to administration or during the trial)
  • Any laboratory value outside the clinically accepted reference range.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

January 1, 2001

Primary Completion

April 1, 2001

Last Updated

June 24, 2014

Record last verified: 2014-06