Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects

Sponsor
TheraVida, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01036035
Collaborator
(none)
18
5
7

Study Details

Study Description

Brief Summary

THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment B

Study drug

Drug: Pilocarpine
Comparison of different dosages of drug

Active Comparator: Treatment D

Study drug

Drug: THVD-201
Comparison of different dosages of drug

Placebo Comparator: Treatment E

Placebo

Drug: placebo capsule
Comparison of different dosages of drug

Active Comparator: Treatment A

Study Drug

Drug: Tolterodine
Comparison of different dosages of drug

Active Comparator: Treatment C

Study Drug

Drug: THVD-201
Comparison of different dosages of drug

Outcome Measures

Primary Outcome Measures

  1. Reductions in stimulated salivary flow (SSF) [From Baseline]

Secondary Outcome Measures

  1. Determine the pharmacokinetics of tolterodine and the agonist. [From Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy males, 18 - 45 years of age.

  • BMI 20-30 m2.

Exclusion Criteria:
  • Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.

  • Clinically significant ECG, vital signs and clinical laboratory indices.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TheraVida, Inc.

Investigators

  • Principal Investigator: Joanne Marjason, Queensland Institute for Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TheraVida, Inc.
ClinicalTrials.gov Identifier:
NCT01036035
Other Study ID Numbers:
  • THVD-201-001
First Posted:
Dec 21, 2009
Last Update Posted:
Dec 30, 2015
Last Verified:
Dec 1, 2015
Keywords provided by TheraVida, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2015