HealthyPhase 1NCT04465266
A Phase 1 PK Study of Tolperisone in Healthy Subjects
A Phase 1 study testing Tolperisone in people with Healthy, run by Neurana Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tolperisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 1 Sep 2021
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally Healthy Subjects
- BMI between 18.5 and 32.5 kg/m2
Who cannot join
- pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Worldwide Clinical Trials Early Phase Services, LLC
San Antonio, Texas, 78217
About this study
Official title: A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
Read the detailed description
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.
- Conditions
- Healthy
- Being tested
- Tolperisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolperisoneDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| 50 mg Tolperisone | Experimental | 50 mg tablets (2 days SD, 2 days TID) Receives: Drug: Tolperisone |
| 100 mg of Tolperisone | Experimental | 100 mg tablets (2 days SD, 2 days TID) Receives: Drug: Tolperisone |
| 200 mg Tolperisone | Experimental | 200 mg tablets (2 days SD, 2 days TID) Receives: Drug: Tolperisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of tolperisone
Measured: taken over 4 days per dose
Tmax
Time of maximum plasma concentration of tolperisone
Measured: taken over 4 days per dose
AUC
Area under the curve of tolperisone plasma concentrations
Measured: taken over 4 days per dose
T1/2
Half life of tolperisone
Measured: taken over 4 days per dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start28 Jul 2020
- Primary completion21 Aug 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- sequence randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurana Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465266
- Sponsor's protocol ID
- CLN-110
- Status last verified
- Jan 2022
- First submitted
- 2 Jul 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04465266
- Acronym / sponsor ID
- CLN-110
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Neurana Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- 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.
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
Detailed description
This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- sequence randomized
| Arm | Type | Receives |
|---|---|---|
| 50 mg Tolperisone | Experimental | Drug: Tolperisone50 mg tablets (2 days SD, 2 days TID) |
| 100 mg of Tolperisone | Experimental | Drug: Tolperisone100 mg tablets (2 days SD, 2 days TID) |
| 200 mg Tolperisone | Experimental | Drug: Tolperisone200 mg tablets (2 days SD, 2 days TID) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Generally Healthy Subjects
- BMI between 18.5 and 32.5 kg/m2
Key exclusion criteria (1 listed)
- pregnant or breastfeeding
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 |
|---|---|---|
| Tolperisonetablets | Drug | 100 mg of Tolperisone, 200 mg Tolperisone, 50 mg Tolperisone |
Primary outcome
Cmax
Time frame: taken over 4 days per dose
Maximum plasma concentration of tolperisone
Tmax
Time frame: taken over 4 days per dose
Time of maximum plasma concentration of tolperisone
AUC
Time frame: taken over 4 days per dose
Area under the curve of tolperisone plasma concentrations
T1/2
Time frame: taken over 4 days per dose
Half life of tolperisone
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 1 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolperisone in people with Healthy, run by Neurana Pharmaceuticals, Inc. at 1 site in United States.
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 1 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Cmax (time frame: taken over 4 days per dose). The study lists 4 primary outcomes in all. 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 1 Feb 2022.