IncontinencePhase 1NCT01036035
Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
A Phase 1 study testing Tolterodine, Pilocarpine and THVD-201 in people with Incontinence, run by TheraVida, Inc..
Trial summary
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Tolterodine, Pilocarpine and THVD-201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, 18 - 45 years of age.
- BMI 20-30 m2.
Who cannot join
- Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
- Clinically significant ECG, vital signs and clinical laboratory indices.
About this study
Official title: 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).
Read the 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.
- Conditions
- Incontinence
- Being tested
- Tolterodine, Pilocarpine, THVD-201, placebo capsule
- Keywords
- Tolterodine, Over active Bladder (OAB), Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolterodineDrug
Comparison of different dosages of drug
PilocarpineDrug
Comparison of different dosages of drug
THVD-201Drug
Comparison of different dosages of drug
THVD-201Drug
Comparison of different dosages of drug
placebo capsuleDrug
Comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment B | Active comparator | Study drug Receives: Drug: Pilocarpine |
| Treatment D | Active comparator | Study drug Receives: Drug: THVD-201 |
| Treatment E | Placebo comparator | Placebo Receives: Drug: placebo capsule |
| Treatment A | Active comparator | Study Drug Receives: Drug: Tolterodine |
| Treatment C | Active comparator | Study Drug Receives: Drug: THVD-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in stimulated salivary flow (SSF)
Measured: From Baseline
Secondary outcomes (1)
Determine the pharmacokinetics of tolterodine and the agonist.
Measured: From Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- TheraVida, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Marjason, Principal investigator, Queensland Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036035
- Sponsor's protocol ID
- THVD-201-001
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2009
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01036035
- Acronym / sponsor ID
- THVD-201-001
- Conditions
- Incontinence
- Keywords
- Tolterodine, Over active Bladder (OAB), Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- TheraVida, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment B | Active comparator | Drug: PilocarpineStudy drug |
| Treatment D | Active comparator | Drug: THVD-201Study drug |
| Treatment E | Placebo comparator | Drug: placebo capsulePlacebo |
| Treatment A | Active comparator | Drug: TolterodineStudy Drug |
| Treatment C | Active comparator | Drug: THVD-201Study Drug |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males, 18 - 45 years of age.
- BMI 20-30 m2.
Key exclusion criteria (2 listed)
- Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
- Clinically significant ECG, vital signs and clinical laboratory indices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolterodineComparison of different dosages of drug | Drug | Treatment A |
| PilocarpineComparison of different dosages of drug | Drug | Treatment B |
| THVD-201Comparison of different dosages of drug | Drug | Treatment C |
| THVD-201Comparison of different dosages of drug | Drug | Treatment D |
| placebo capsuleComparison of different dosages of drug | Drug | Treatment E |
Primary outcome
Reductions in stimulated salivary flow (SSF)
Time frame: From Baseline
1 secondary outcome
Determine the pharmacokinetics of tolterodine and the agonist.
Time frame: From Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Marjason principal investigator
Queensland Institute for Medical Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolterodine, Pilocarpine and THVD-201 in people with Incontinence, run by TheraVida, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in stimulated salivary flow (SSF) (time frame: From Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.