Trials / Completed
CompletedNCT03195946
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study will help determine which types of drugs that may interact with Lu AF35700
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AF35700 | tablets for oral use, 10 mg/day |
| DRUG | Midazolam | syrup for oral use, 4mg/day |
| DRUG | Cocktail of CYP450 substrates | Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day |
Timeline
- Start date
- 2017-06-16
- Primary completion
- 2018-01-03
- Completion
- 2018-01-03
- First posted
- 2017-06-22
- Last updated
- 2018-01-08
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03195946. Inclusion in this directory is not an endorsement.