Trials / Terminated
TerminatedNCT02244112
A Phase 1 Study of Oprozomib to Assess Food Effect, Drug-Drug Interaction With Midazolam, and Safety and Tolerability in Patients With Advanced Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase 1 of the study is to evaluate the effect of food on the pharmacokinetics (PK) of oprozomib, the drug-drug interaction of oprozomib with midazolam, and the safety and tolerability of oprozomib in patients with advanced malignancies
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oprozomib | Subjects will receive oprozomib 270 mg per dose in Part I and oprozomib 300 mg per dose in Part II. |
| DRUG | Midazolam | Subjects will receive a single oral dose of midazolam 2 mg in Period 1 and oral midazolam 2 mg per dose in Period 2. |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-05-15
- Completion
- 2019-07-10
- First posted
- 2014-09-18
- Last updated
- 2021-02-21
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02244112. Inclusion in this directory is not an endorsement.