A Study of Ralinepag in Healthy Chinese Adult Subjects

Sponsor
Everstar Medicines (Shanghai) Limited
Study ID
NCT04613999
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer
  • Pharmacokinetic Study

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Ralinepag — DRUG
    Ralinepag will be supplied as 50 mcg round, orange, XR tablets for oral administration. It is planned that every subject will receive each of the following regimens in the fasted state: * Regimen A (50 mcg): 1 × 50 mcg ralinepag XR tablet * Regimen B (100 mcg): 2 × 50 mcg ralinepag XR tablets * Regimen C (150 mcg): 3 × 50 mcg ralinepag XR tablets Subjects will receive Regimens A, B and C in a sequential manner in consecutive treatment periods. Subjects who have tolerated the IMP in all prior regimens will continue in the study to receive each subsequent dose.

Study Details

A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese Subjects.

Key Dates

Start date
Oct 9, 2020
Status verified
Jan 2024
Primary completion
Nov 9, 2020
Completion
Nov 9, 2020

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm
    Subjects will receive regimens 50 mcg, 100 mcg and 150 mcg in a sequential manner in consecutive treatment periods. Subjects who have tolerated the IMP in all prior regimens will continue in the study to receive each subsequent dose.

Primary Outcome Measure

Cmax [ Time Frame: Baseline to 96 hours ]

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