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

This study has been completed.
Information provided by (Responsible Party):
TheraVida, Inc.
ClinicalTrials.gov Identifier:
First received: December 16, 2009
Last updated: December 28, 2015
Last verified: December 2015
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Condition Intervention Phase
Drug: Tolterodine
Drug: Pilocarpine
Drug: THVD-201
Drug: placebo capsule
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects

Resource links provided by NLM:

Further study details as provided by TheraVida, Inc.:

Primary Outcome Measures:
  • Reductions in stimulated salivary flow (SSF) [ Time Frame: From Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the pharmacokinetics of tolterodine and the agonist. [ Time Frame: From Baseline ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01036035

Sponsors and Collaborators
TheraVida, Inc.
Principal Investigator: Joanne Marjason Queensland Institute for Medical Research
  More Information

Responsible Party: TheraVida, Inc.
ClinicalTrials.gov Identifier: NCT01036035     History of Changes
Other Study ID Numbers: THVD-201-001 
Study First Received: December 16, 2009
Last Updated: December 28, 2015
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by TheraVida, Inc.:
Over active Bladder (OAB)

Additional relevant MeSH terms:
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Muscarinic Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on May 02, 2016