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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06930872




Registration number
NCT06930872
Ethics application status
Date submitted
9/04/2025
Date registered
16/04/2025
Date last updated
1/07/2025

Titles & IDs
Public title
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
Scientific title
A Phase 1, Open Label, Drug Interaction Study to Evaluate the Effect of ZYN002 on the Pharmacokinetics of CYP3A4, CYP2C19, CYP2C9, CYP2D6, CYP1A2, CYP2C8, and CYP2B6 Probe Substrates, and Valproate in Healthy Adult Participants
Secondary ID [1] 0 0
ZYN2-CL-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Part 1
Treatment: Drugs - Part 2

Experimental: Part 1: Interaction of ZYN002 and substrates - Substrates: midazolam, omeprazole, losartan, dextromethorphan, caffeine, repaglinide, and bupropion

Experimental: Part 2: Interaction of ZYN002 and VPA -


Treatment: Drugs: Part 1
ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)

Treatment: Drugs: Part 2
ZYN002 (transdermal), VPA (oral)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum measure plasma concentration (Cmax) of probe substrates and metabolites
Timepoint [1] 0 0
Days 1-3 (Period 1), Days 24-26 (Period 3)
Primary outcome [2] 0 0
Cmax of repaglinide and metabolite
Timepoint [2] 0 0
Days 3 and 4 (Period 1), Days 26 and 27 (Period 3)
Primary outcome [3] 0 0
Cmax of bupropion and metabolite
Timepoint [3] 0 0
Days 4-10 (Period 1), Days 27-33 (Period 3)
Primary outcome [4] 0 0
Cmax of CBD, delta-9-tetrahydrocannabinol (THC), and CBD metabolites
Timepoint [4] 0 0
Days 24-33 (Period 3)
Primary outcome [5] 0 0
Amount excreted in urine over the collection period (Ae0-12) of CBD and its metabolites
Timepoint [5] 0 0
Day 17 (Period 2), Days 24 and 32 (Period 3)
Primary outcome [6] 0 0
Cmax of VPA and metabolite
Timepoint [6] 0 0
Days 1-4 (Period 1), Days 18-21 (Period 3)
Primary outcome [7] 0 0
Cmax of CBD, THC, and CBD metabolites
Timepoint [7] 0 0
Days 18-21 (Period 3)
Primary outcome [8] 0 0
Ae0-12 of VPA and metabolites
Timepoint [8] 0 0
Days 1-4 (Period 1), Day 17 (Period 2), Days 18-20 (Period 3)
Primary outcome [9] 0 0
Ae0-12 of ZYN002 and metabolites
Timepoint [9] 0 0
Day 17 (Period 2), Days 18 and 20 (Period 3)
Secondary outcome [1] 0 0
Number of participants with skin irritation in ZYN002 application areas
Timepoint [1] 0 0
Up to 33 days
Secondary outcome [2] 0 0
Number of participants with abnormal physical examination results
Timepoint [2] 0 0
Up to 33 days
Secondary outcome [3] 0 0
Number of participants with abnormal clinical laboratory results
Timepoint [3] 0 0
Up to 33 days
Secondary outcome [4] 0 0
Number of participants with abnormal vital sign results
Timepoint [4] 0 0
Up to 33 days
Secondary outcome [5] 0 0
Number of participants with abnormal continuous pulse oximetry results
Timepoint [5] 0 0
Up to 33 days
Secondary outcome [6] 0 0
Number of participants with abnormal electrocardiogram (ECG)
Timepoint [6] 0 0
Up to 33 days

Eligibility
Key inclusion criteria
1. Male or female adults, 18-55 years of age, inclusive, at the time of Screening.
2. 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.
3. Participants must have a body mass index between 18 and 30 kg/m² at the time of Screening.
4. 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.
2. 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.
3. Has consumed alcohol 48 hours prior to Day 1 or during the study.
4. 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).

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Harmony Biosciences Management, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Polasek, MD, PhD
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarada Radha, PhD, ACRP-CP
Address 0 0
Country 0 0
Phone 0 0
+61 (0)8 7088 7900
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06930872