Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects

January 24, 2025 updated by: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

An Open Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Dose and Repeat Dose Topical Administrations of Clascoterone Cream, 1% in Healthy Chinese Adult Subjects

The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • London, China, N1 9JP
        • Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Chinese adult subjects, male or female;
  • 18-45 years of age (18 years old and 45 years old are inclusive, on the day of signing the written informed consent);
  • Males should be ≥50.0 kg females should be ≥45.0 kg, respectively, and their body mass index [BMI = weight (kg)/height2 (m2)] should be within the range of 19.0 to 28.0 kg/m2 (including critical value);
  • Female subjects of childbearing potential or male subjects whose partners are of childbearing potential should agree and be able to use effective contraception from the time of signing the written informed consent to within 3 months after the last dosing (see Appendix 2 for details);
  • Subjects should be able to communicate well with the investigator and complete the study as per the protocol; subjects should be fully informed about the study and sign a written informed consent voluntarily.

Exclusion Criteria:

  • Subject has a previous history of chronic or serious disease;
  • Subject who has undergone major surgical procedure or procedure affecting drug absorption, distribution, metabolism, or excretion within 6 months prior to screening, or plans to undergo surgery during the study;
  • Subject has a history of drug abuse and drug dependence;
  • Subject who has received any medication prior to screening;
  • Subject has previous allergies or has allergic symptoms;
  • Subject has skin damages;
  • Subject who has consumed alcohol regularly;
  • Subject has positive testing result of drug abuse and narcotics screening ;
  • Subject who has consumed excessive of strong tea, coffee, or caffeine-containing beverages;
  • Subject who has been addicted to smoking;
  • Subject who has intake of grapefruit-rich beverages or foods;
  • Subject who has participated in a clinical study with another drug or device and has used the drug or device prior to screening
  • Subject who has donated blood or bled heavily , or received a blood transfusion or used blood products; or who plans to donate blood or blood components;
  • Subject has abnormal physical examination result at screening, or abnormal result of vital signs, or abnormal ECG findings;
  • Subject has abnormal and clinically significant results of clinical laboratory tests;
  • Subject who is a pregnant or lactation woman or has positive pregnancy test result;
  • Subject who is unable to follow a uniform diet;
  • Subject who has difficulty in collecting blood, has a history of needle and blood fainting or cannot tolerate venipuncture;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Clascoterone Cream 1%
Drug: Clascoterone Cream 1%
Clascoterone Cream 1% (Winlevi) is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to maximum plasma concentration (Tmax)
Time Frame: Day 1
Time to maximum plasma concentration
Day 1
Maximum plasma concentration (Cmax)
Time Frame: Day 1
Maximum plasma concentration
Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Time Frame: Day 1
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration
Day 1
Time to maximum plasma concentration (Tmax)
Time Frame: Day 7
Time to maximum plasma concentration
Day 7
Maximum plasma concentration at steady state (Cmax,ss)
Time Frame: Day 7
Maximum plasma concentration at steady state
Day 7
Minimum plasma concentration at steady state (Cmin,ss)
Time Frame: Day 7
Minimum plasma concentration at steady state
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AEs and SAEs
Time Frame: Day 7
Incidence and severity of all adverse events (AEs) and serious adverse events (SAEs), and their relevance with the investigational drug.
Day 7
Temperature
Time Frame: Day 7
Incidence of abnormal clinically significant temperature results.
Day 7
Pulse rate
Time Frame: Day 7
Incidence of abnormal clinically significant pulse rate results.
Day 7
Blood pressure
Time Frame: Day 7
Incidence of abnormal clinically significant blood pressure results.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LWY23090P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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