Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates

NCT06930872 | Completed Phase 1

• 1 other identifier: ZYN2-CL-007
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.

Conditions

Drug Interaction

Outcome Measures

Primary Outcomes (9)

• Maximum measure plasma concentration (Cmax) of probe substrates and metabolites

  Blood samples collected at pre dose, and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose.

  Days 1-3 (Period 1), Days 24-26 (Period 3)

• Cmax of repaglinide and metabolite

  Blood samples collected at pre dose, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose.

  Days 3 and 4 (Period 1), Days 26 and 27 (Period 3)

• Cmax of bupropion and metabolite

  Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post dose.

  Days 4-10 (Period 1), Days 27-33 (Period 3)

• Cmax of CBD, delta-9-tetrahydrocannabinol (THC), and CBD metabolites

  Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, and 144 hours post dose.

  Days 24-33 (Period 3)

• Amount excreted in urine over the collection period (Ae0-12) of CBD and its metabolites

  Urine samples collected over a 12-hour period.

  Day 17 (Period 2), Days 24 and 32 (Period 3)

• Cmax of VPA and metabolite

  Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose.

  Days 1-4 (Period 1), Days 18-21 (Period 3)

• Cmax of CBD, THC, and CBD metabolites

  Blood samples collected at pre dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post dose.

  Days 18-21 (Period 3)

• Ae0-12 of VPA and metabolites

  Urine samples collected over a 12-hour period.

  Days 1-4 (Period 1), Day 17 (Period 2), Days 18-20 (Period 3)

• Ae0-12 of ZYN002 and metabolites

  Urine samples collected over a 12-hour period.

  Day 17 (Period 2), Days 18 and 20 (Period 3)

Secondary Outcomes (6)

• Number of participants with skin irritation in ZYN002 application areas

  Up to 33 days

• Number of participants with abnormal physical examination results

  Up to 33 days

• Number of participants with abnormal clinical laboratory results

  Up to 33 days

• Number of participants with abnormal vital sign results

  Up to 33 days

• Number of participants with abnormal continuous pulse oximetry results

  Up to 33 days

Study Arms (2)

Part 1: Interaction of ZYN002 and substrates

EXPERIMENTAL

Substrates: midazolam, omeprazole, losartan, dextromethorphan, caffeine, repaglinide, and bupropion

Drug: Part 1

Part 2: Interaction of ZYN002 and VPA

EXPERIMENTAL

Drug: Part 2

Interventions

Part 1 DRUG

ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)

Also known as: Synthetic cannabidiol (sCBD)

Part 1: Interaction of ZYN002 and substrates

Part 2 DRUG

ZYN002 (transdermal), VPA (oral)

Also known as: sCBD

Part 2: Interaction of ZYN002 and VPA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Harmony Biosciences Management, Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Thomas Polasek, MD, PhD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

• Kristen Bzdek, MD

  Harmony Biosciences Management, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label, 2-part, fixed-sequence DDI study.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Participants will receive probe substrates in Periods 1 and 3 and ZYN002 treatment in Periods 2 and 3. Part 2: Participants will receive probe substrate in Periods 1 and 3 and ZYN002 treatment in Periods 2 and 3.

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: June 6, 2025
• Primary Completion: October 4, 2025
• Study Completion: November 4, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

AU (1)