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

December 28, 2015 updated by: TheraVida, Inc.

Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reductions in stimulated salivary flow (SSF)
Time Frame: From Baseline
From Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine the pharmacokinetics of tolterodine and the agonist.
Time Frame: From Baseline
From Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TheraVida, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THVD-201-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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