Part 1
ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)
Synthetic cannabidiol (sCBD)Loading study record…
This study is an open-label drug-drug interaction (DDI) study of ZYN002 transdermal gel and multiple drugs.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-09
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)
Synthetic cannabidiol (sCBD)ZYN002 (transdermal), VPA (oral)
sCBDEligibility
primary outcomes
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.
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.
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.
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.
Time frame: Day 17 (Period 2), Days 24 and 32 (Period 3)
Urine samples collected over a 12-hour period.
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.
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.
Time frame: Days 1-4 (Period 1), Day 17 (Period 2), Days 18-20 (Period 3)
Urine samples collected over a 12-hour period.
Time frame: Day 17 (Period 2), Days 18 and 20 (Period 3)
Urine samples collected over a 12-hour period.
secondary outcomes
Time frame: Up to 33 days
Skin assessment examination
Time frame: Up to 33 days
Targeted physical examination
Time frame: Up to 33 days
Laboratory testing
Time frame: Up to 33 days
Vital Sign measures
Time frame: Up to 33 days
Continuous pulse oximeter
Time frame: Up to 33 days
12-lead ECG
Publications
No exact PMID-linked public article is currently readable locally.