Drug InteractionPhase 1NCT06930872
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
A Phase 1 study testing Part 1 and Part 2 in people with Drug Interaction, run by Harmony Biosciences Management, Inc. at 1 site in Australia.
Trial summary
This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- Part 1 and Part 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Jun 2025to 4 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.
Read the 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. In addition, this study is designed to evaluate the safety and tolerability of ZYN002 transdermal gel after multiple-dose topical application to healthy adult participants.
Part 1 - DDI with probe substrates for cytochrome P450 (CYP)3A4, CYP2C19, CYP2C9, CYP2D6, CYP1A2 administered as single oral doses followed by the staggered dosing of probe substrates for CYP2C8 and for CYP2B6 administered as single oral doses.
Part 2 - DDI with valproate (valproic acid [VPA]), a probe substrate for β-oxidation and glucuronidation.
- Conditions
- Drug Interaction
- Being tested
- Part 1, Part 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1Drug
Also called Synthetic cannabidiol (sCBD)
ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)
Part 2Drug
Also called sCBD
ZYN002 (transdermal), VPA (oral)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Interaction of ZYN002 and substrates | Experimental | Substrates: midazolam, omeprazole, losartan, dextromethorphan, caffeine, repaglinide, and bupropion Receives: Drug: Part 1 |
| Part 2: Interaction of ZYN002 and VPA | Experimental | Not described Receives: Drug: Part 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 18-21 (Period 3)
Ae0-12 of VPA and metabolites
Urine samples collected over a 12-hour period.
Measured: 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.
Measured: Day 17 (Period 2), Days 18 and 20 (Period 3)
Secondary outcomes (6)
Number of participants with skin irritation in ZYN002 application areas
Skin assessment examination
Measured: Up to 33 days
Number of participants with abnormal physical examination results
Targeted physical examination
Measured: Up to 33 days
Number of participants with abnormal clinical laboratory results
Laboratory testing
Measured: Up to 33 days
Number of participants with abnormal vital sign results
Vital Sign measures
Measured: Up to 33 days
Number of participants with abnormal continuous pulse oximetry results
Continuous pulse oximeter
Measured: Up to 33 days
Number of participants with abnormal electrocardiogram (ECG)
12-lead ECG
Measured: Up to 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start6 Jun 2025
- Primary completion4 Oct 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Polasek, MD, PhD, Principal investigator, CMAX Clinical ResearchKristen Bzdek, MD, Study director, Harmony Biosciences Management, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930872
- Sponsor's protocol ID
- ZYN2-CL-007
- Status last verified
- Feb 2026
- First submitted
- 9 Apr 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06930872
- Acronym / sponsor ID
- ZYN2-CL-007
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Harmony Biosciences Management, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 4 Oct 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. In addition, this study is designed to evaluate the safety and tolerability of ZYN002 transdermal gel after multiple-dose topical application to healthy adult participants.
Part 1 - DDI with probe substrates for cytochrome P450 (CYP)3A4, CYP2C19, CYP2C9, CYP2D6, CYP1A2 administered as single oral doses followed by the staggered dosing of probe substrates for CYP2C8 and for CYP2B6 administered as single oral doses.
Part 2 - DDI with valproate (valproic acid [VPA]), a probe substrate for β-oxidation and glucuronidation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Interaction of ZYN002 and substrates | Experimental | Drug: Part 1Substrates: midazolam, omeprazole, losartan, dextromethorphan, caffeine, repaglinide, and bupropion |
| Part 2: Interaction of ZYN002 and VPA | Experimental | Drug: Part 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1Also: Synthetic cannabidiol (sCBD)ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral) | Drug | Part 1: Interaction of ZYN002 and substrates |
| Part 2Also: sCBDZYN002 (transdermal), VPA (oral) | Drug | Part 2: Interaction of ZYN002 and VPA |
Primary outcome
Maximum measure plasma concentration (Cmax) of probe substrates and metabolites
Time frame: Days 1-3 (Period 1), Days 24-26 (Period 3)
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.
Cmax of repaglinide and metabolite
Time frame: Days 3 and 4 (Period 1), Days 26 and 27 (Period 3)
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.
Cmax of bupropion and metabolite
Time frame: Days 4-10 (Period 1), Days 27-33 (Period 3)
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.
Cmax of CBD, delta-9-tetrahydrocannabinol (THC), and CBD metabolites
Time frame: Days 24-33 (Period 3)
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.
Amount excreted in urine over the collection period (Ae0-12) of CBD and its metabolites
Time frame: Day 17 (Period 2), Days 24 and 32 (Period 3)
Urine samples collected over a 12-hour period.
Cmax of VPA and metabolite
Time frame: Days 1-4 (Period 1), Days 18-21 (Period 3)
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.
Cmax of CBD, THC, and CBD metabolites
Time frame: Days 18-21 (Period 3)
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.
Ae0-12 of VPA and metabolites
Time frame: Days 1-4 (Period 1), Day 17 (Period 2), Days 18-20 (Period 3)
Urine samples collected over a 12-hour period.
Ae0-12 of ZYN002 and metabolites
Time frame: Day 17 (Period 2), Days 18 and 20 (Period 3)
Urine samples collected over a 12-hour period.
6 secondary outcomes
Number of participants with skin irritation in ZYN002 application areas
Time frame: Up to 33 days
Number of participants with abnormal physical examination results
Time frame: Up to 33 days
Number of participants with abnormal clinical laboratory results
Time frame: Up to 33 days
Number of participants with abnormal vital sign results
Time frame: Up to 33 days
Number of participants with abnormal continuous pulse oximetry results
Time frame: Up to 33 days
Number of participants with abnormal electrocardiogram (ECG)
Time frame: Up to 33 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Polasek, MD, PhD principal investigator
CMAX Clinical Research
Kristen Bzdek, MD study director
Harmony Biosciences Management, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part 1 and Part 2 in people with Drug Interaction, run by Harmony Biosciences Management, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measure plasma concentration (Cmax) of probe substrates and metabolites (time frame: Days 1-3 (Period 1), Days 24-26 (Period 3)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.