A Study of Ralinepag in Healthy Chinese Adult Subjects

NCT04613999 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ES102102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer; Pharmacokinetic Study

Keywords

Healthy volunteer; Pharmacokinetic, safety and tolerability; Ralinepag

Outcome Measures

Primary Outcomes (6)

• Cmax

  Maximum concentration determined directly from the concentration-time profile

  Baseline to 96 hours

• Tmax

  Time to maximum concentration determined directly from the concentration-time profile

  Baseline to 96 hours

• T1/2

  Terminal elimination half-life calculated as: ln2/λz

  Baseline to 96 hours

• AUC0-24

  Area under the concentration-time curve (AUC) from pre-dose (time 0) to 24 hours post-dose calculated using the linear-log trapezoidal rule

  Baseline to 96 hours

• AUClast

  AUC from time zero to the time of the last quantifiable concentration (Tlast) calculated using the linear-log trapezoidal rule

  Baseline to 96 hours

• AUCinf

  AUC from pre-dose (Time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule

  Baseline to 96 hours

Secondary Outcomes (73)

• Adverse event reporting

  From signing ICF to 10 days after last dose.

• Assessment of general appearance of dermatologic.

  From signing ICF to 10 days after last dose.

• Assessment of general appearance of head.

  From signing ICF to 10 days after last dose.

• Assessment of general appearance of eyes.

  From signing ICF to 10 days after last dose.

• Assessment of general appearance of ears.

  From signing ICF to 10 days after last dose.

Study Arms (1)

Single Arm

OTHER

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.

Drug: Ralinepag

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy subjects aged 18 to 45 years at the time of signing the informed consent form (ICF).
• \. Body mass index of 19.0 to 25.0 kg/m2.
• \. In good general health, free from clinically significant medical or psychiatric illness or disease (as determined by medical/surgical history, physical examination, weight, 12-lead ECG and clinical laboratory tests).
• \. HIV, Syphilitics, Hepatitis B and Hepatitis C negative at the screening evaluation.
• \. Adequate venous access in the left or right arm to allow for collection of a number of blood samples
• \. Provides written informed consent.
• \. Willing to comply with all study procedures and requirements.
• \. Subjects of reproductive potential must agree to use an approved method of contraception from Day -1 until 30 days after study discharge:
• Barrier method (e.g., condom) plus an approved method of highly effective contraception or
• Female/male partner is surgically sterile.

You may not qualify if:

• \. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
• \. History or presence of any clinically significant psychiatric condition (including depression or prior suicidal behaviour).
• \. History of dysphagia.
• \. Clinically significant surgical procedure or traumatic injury within 3 months of screening.
• \. History of epilepsy (other than febrile seizures during childhood).
• \. Clinically significant infection within 28 days of start of dosing.
• \. Currently suffers from clinically significant systemic allergic disease or has a history of significant drug allergies including a history of anaphylactic reaction (particularly reactions to general anesthetic agents); allergic reaction due to any drug which led to significant morbidity.
• \. History or presence of cardiac arrhythmia or congenital long QT syndrome.
• \. QTcF \>450 msec, PR \>220 msec and QRS \>120 msec on screening ECG (ECG may be repeated after consultation with the Medical Monitor).
• \. Use of tobacco or nicotine containing products in the previous 6 months prior to dosing or use of a nicotine patch within 14 days prior to screening.
• \. Regular alcohol consumption \> 2 units/day (1 unit = 300 mL of beer or 45 mL of alcohol 40% or 150mL of wine) or alcohol consumption within 48 hours of start of dosing.
• \. Positive urine drug or alcohol breathalyzer test prior to study entry or history of alcohol or drug abuse in the last 12 months.
• \. Use of any prescription medication within 14 days prior to screening.
• \. Use of any over the counter (OTC) medication, herbal or hormone supplements, or diet aids within 14 days prior to screening
• \. Participation in any other investigational trial in which the last dose of study drug occurred within 30 days or 5 half-lives (whichever is longer) before Check-in for Inpatient Period (Day -1)

Sponsors & Collaborators

• Everstar Medicines (Shanghai) Limited: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

ralinepag

Study Officials

• Haiyan Li

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is planned to enroll 15 subjects with open-label, fixed sequence, non-randomized to take a single dose of ralinepag at 3 separate dose intervals. Ralinepag will be administered at doses of 50, 100 and 150 mcg single oral each time. Subjects will receive Regimen A (single dose of ralinepag 50 mcg) in the morning of Day 1 and pharmacokinetic assessments will be conducted pre-dose and over the 96 hours post-dose. There will be a washout period of 7 days between each IMP administration. Regimens B and C (single dose of ralinepag 100 mcg and ralinepag 150 mcg) will be administered following an overnight fast on Day 8 and 15, respectively, with 96 hours of pharmacokinetic assessments as performed with Regimen A. A Follow-up phone call will take place 10±1 days post-last dose to ensure the ongoing well-being of the subjects.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: November 3, 2020
• Study Start: October 9, 2020
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)