Trials / Completed
CompletedNCT04410094
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
A Phase 1 Open-Label, Fixed-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Steady-state Itraconazole and Rifampin on the Single-dose Pharmacokinetics of Lazertinib Tablets in Healthy Adult Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in healthy adult participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lazertinib | Lazertinib tablets will be administered orally. |
| DRUG | Itraconazole | Itraconazole capsules will be administered orally. |
| DRUG | Rifampin | Rifampin capsules will be administered orally. |
Timeline
- Start date
- 2020-09-14
- Primary completion
- 2020-12-30
- Completion
- 2021-02-02
- First posted
- 2020-06-01
- Last updated
- 2021-03-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04410094. Inclusion in this directory is not an endorsement.