Status:
RECRUITING
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
Lead Sponsor:
Harmony Biosciences Management, Inc.
Conditions:
Drug Interaction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.
Detailed Description
This study is a Phase 1, open-label, 2-part, fixed-sequence, 3-period DDI study to evaluate the effect of ZYN002 transdermal gel on the pharmacokinetics (PK) of probe substrates and their metabolites....
Eligibility Criteria
Inclusion
- Male or female adults, 18-55 years of age, inclusive, at the time of Screening.
- Judged by the Investigator to be in generally good health at Screening based upon the results of a medical history, physical examination, 12-lead ECG, and clinical laboratory test results. Laboratory results outside of the reference range, but acceptable, must be documented as not clinically significant (NCS) at the discretion of the Investigator.
- Participants must have a body mass index between 18 and 30 kg/m² at the time of Screening.
- Females of childbearing potential must have a negative pregnancy test result at the Screening Visit and on Day -1 before admission to the CRU. Females who are not of childbearing potential are defined as being postmenopausal for \>=12 months or having a history of hysterectomy and/or bilateral oophorectomy and/or bilateral tubal ligation.
Exclusion
- A) Females who are pregnant, nursing or planning to become pregnant or females of childbearing potential, who are unwilling to use medically acceptable method of contraception or B) Males with a female partner who is pregnant, nursing, or planning to become pregnant or a female partner of childbearing potential who is unwilling to use a medically acceptable method of contraception.
- Are homozygous for CYP2C19\*2 or heterozygous carriers of CYP2C19\*2/CYP2C19\*3 or CYP2C9\*2/CYP2C9\*3 or CYP2D6\*2/CYP2D6\*3 haplotypes categorized as poor metabolizers.
- Has consumed alcohol 48 hours prior to Day 1 or during the study.
- Has eaten any food or drink/beverage containing, grapefruit or grapefruit juice, apple, cranberry, Seville orange or orange juice, vegetables from the mustard family (e.g., kale, spinach, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, parsley, mustard greens, endive, red cabbage, asparagus, or mustard), and chargrilled meats within one week prior to study start (Day -1).
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06930872
Start Date
June 6 2025
End Date
November 1 2025
Last Update
August 5 2025
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000