Trials / Completed
CompletedNCT04405323
Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
Detailed description
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences. For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lu AG06466 | hard capsules, orally, single doses |
| DRUG | Itraconazole | 200 and 300 mg, capsules, orally |
Timeline
- Start date
- 2020-05-20
- Primary completion
- 2020-07-28
- Completion
- 2020-07-28
- First posted
- 2020-05-28
- Last updated
- 2020-08-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04405323. Inclusion in this directory is not an endorsement.