A PK Dose Proportionality Study of OPL-002 in Healthy Volunteers
NCT04451811 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2021-05-28
Summary
This is a single center, randomized, open-label, three-way crossover, single dose, pharmacokinetic dose proportionality study of oral OPL-002 in healthy subjects.
Conditions
- Healthy
Interventions
- DRUG
-
OPL-002
Spray dried dispersion and tablet formulation
Sponsors & Collaborators
-
Celerion
collaborator INDUSTRY -
Oppilan Pharma Ltd
lead INDUSTRY
Principal Investigators
-
Richard Gregg, MD · Oppilan Pharma Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-07
- Primary Completion
- 2021-02-24
- Completion
- 2021-02-24
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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