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

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ClinicalTrials.gov Identifier: NCT01036035
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
TheraVida, Inc.

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

Condition or disease Intervention/treatment Phase
Incontinence Drug: Tolterodine Drug: Pilocarpine Drug: THVD-201 Drug: placebo capsule 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 Type : Interventional  (Clinical Trial)
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 : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Reductions in stimulated salivary flow (SSF) [ Time Frame: From Baseline ]

Secondary Outcome Measures :
  1. Determine the pharmacokinetics of tolterodine and the agonist. [ Time Frame: From Baseline ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036035


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

Responsible Party: TheraVida, Inc.
ClinicalTrials.gov Identifier: NCT01036035     History of Changes
Other Study ID Numbers: THVD-201-001
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Tolterodine Tartrate
Pilocarpine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Agonists
Cholinergic Agonists