A Phase 1 PK Study of Tolperisone in Healthy Subjects

• Sponsor: Neurana Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04465266
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 3
• Actual Duration (Months): 13.1
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Tolperisone	Phase 1

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

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: sequence randomizedsequence randomized
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects
• Actual Study Start Date: Jul 28, 2020
• Actual Primary Completion Date: Aug 21, 2020
• Actual Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50 mg Tolperisone 50 mg tablets (2 days SD, 2 days TID)	Drug: Tolperisone; tablets
Experimental: 100 mg of Tolperisone 100 mg tablets (2 days SD, 2 days TID)	Drug: Tolperisone; tablets
Experimental: 200 mg Tolperisone 200 mg tablets (2 days SD, 2 days TID)	Drug: Tolperisone; tablets

Outcome Measures

Primary Outcome Measures

1. Cmax [taken over 4 days per dose]

   Maximum plasma concentration of tolperisone

2. Tmax [taken over 4 days per dose]

   Time of maximum plasma concentration of tolperisone

3. AUC [taken over 4 days per dose]

   Area under the curve of tolperisone plasma concentrations

4. T1/2 [taken over 4 days per dose]

   Half life of tolperisone

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Generally Healthy Subjects

• BMI between 18.5 and 32.5 kg/m2

Exclusion Criteria:

• pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas	United States	78217

Sponsors and Collaborators

• Neurana Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neurana Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04465266
• Other Study ID Numbers: CLN-110
• First Posted: Jul 10, 2020
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tolperisone

Study Results

No Results Posted as of Feb 1, 2022