Healthy VolunteerPhase 1NCT04613999
A Study of Ralinepag in Healthy Chinese Adult Subjects
A Phase 1 study testing Ralinepag in people with Healthy Volunteer and Pharmacokinetic Study, run by Everstar Medicines (Shanghai) Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Pharmacokinetic Study
- What is being tested?
- Ralinepag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 9 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy subjects aged 18 to 45 years at the time of signing the informed consent form (ICF).
- 2. Body mass index of 19.0 to 25.0 kg/m2.
- 3. 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).
- 4. HIV, Syphilitics, Hepatitis B and Hepatitis C negative at the screening evaluation.
- 5. Adequate venous access in the left or right arm to allow for collection of a number of blood samples
- 6. Provides written informed consent.
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- 7. Willing to comply with all study procedures and requirements.
- 8. 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.
Who cannot join
- 1. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
- 2. History or presence of any clinically significant psychiatric condition (including depression or prior suicidal behaviour).
- 3. Evidence of clinically relevant medical illness, cardiovascular, hematological, gastrointestinal, hepatic, renal, rheumatologic, endocrine, pulmonary, neurologic, psychiatric or skin disorder (excluding skin cancer as described in Exclusion Criterion 1) or history of hypertension or heart disease including any abnormal laboratory results deemed clinically significant by the study investigator at screening.
- 4. History of dysphagia.
- 5. Clinically significant surgical procedure or traumatic injury within 3 months of screening.
- 6. History of epilepsy (other than febrile seizures during childhood).
Show all 23Show fewer
- 7. Clinically significant infection within 28 days of start of dosing.
- 8. 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.
- 9. History or presence of cardiac arrhythmia or congenital long QT syndrome.
- 10. QTcF >450 msec, PR >220 msec and QRS >120 msec on screening ECG (ECG may be repeated after consultation with the Medical Monitor).
- 11. 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.
- 12. 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.
- 13. Positive urine drug or alcohol breathalyzer test prior to study entry or history of alcohol or drug abuse in the last 12 months.
- 14. Use of any prescription medication within 14 days prior to screening.
- 15. Use of any over the counter (OTC) medication, herbal or hormone supplements, or diet aids within 14 days prior to screening
- 16. 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)
- 17. Donation of blood from 30 days before Check-in for Inpatient Period (Day -1) or of plasma from 2 weeks before Check-in for Inpatient Period (Day -1)
- 18. Receipt of blood products within 2 months before Check-in for Inpatient Period (Day -1)
- 19. Abnormal supine BP (defined as either systolic BP > 140 millimetres (mm) Hg or < 90 mmHg or diastolic BP > 90 mmHg or < 50 mmHg) or abnormal pulse rate (> 100 beats per minute [bpm] or < 50 bpm), confirmed by at least 1 repeat measurement
- 20. Abnormal orthostatic BP at Screening or CPC Check-in on Day -1 (defined as confirmed drop in SBP > 20 mmHg or drop in DBP > 10 mmHg with standing). The assessment may be repeated once to assure adequate hydration.
- 21. Women who are pregnant, lactating or breast-feeding.
- 22. Known hypersensitivity to any of the excipients of Ralinepag.
- 23. Any inappropriate condition to participate in the study considered by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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
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.
Read the detailed description
This is a single center, open-label, fixed sequence, non-randomized study of healthy subjects. The study is planned to enroll 15 subjects to ensure data for 8 evaluable subjects.
Subjects will visit the clinical unit for a screening visit up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit prior to investigational medicinal product (IMP) administration (Day -1) and will remain onsite through the study discharge on Day 19. Following an overnight fast of at least 8 hours, 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. Ralinepag (APD811) 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.
- Conditions
- Healthy Volunteer, Pharmacokinetic Study
- Being tested
- Ralinepag
- Keywords
- Healthy volunteer, Pharmacokinetic, safety and tolerability, Ralinepag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RalinepagDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ralinepag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration determined directly from the concentration-time profile
Measured: Baseline to 96 hours
Tmax
Time to maximum concentration determined directly from the concentration-time profile
Measured: Baseline to 96 hours
T1/2
Terminal elimination half-life calculated as: ln2/λz
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 96 hours
Secondary outcomes (73)
Adverse event reporting
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of dermatologic.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of head.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of eyes.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of ears.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of mouth.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of throat.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of neck.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of thyroid.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of lymph nodes.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of respiratory system.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of cardiovascular system.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of gastrointestinal system.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of extremities.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of musculoskeletal system.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of neurologic system.
Measured: From signing ICF to 10 days after last dose.
Assessment of general appearance of psychiatric system.
Measured: From signing ICF to 10 days after last dose.
Serum alanine aminotransferase (ALT)
Measured: From signing ICF to 10 days after last dose.
Serum glucose
Measured: From signing ICF to 10 days after last dose.
Serum albumin
Measured: From signing ICF to 10 days after last dose.
Serum lactate dehydrogenase (LDH)
Measured: From signing ICF to 10 days after last dose.
Serum alkaline phosphatase (ALP)
Measured: From signing ICF to 10 days after last dose.
Serum phosphorus
Measured: From signing ICF to 10 days after last dose.
Serum aspartate aminotransferase (AST)
Measured: From signing ICF to 10 days after last dose.
Serum potassium
Measured: From signing ICF to 10 days after last dose.
Serum blood urea
Measured: From signing ICF to 10 days after last dose.
Serum sodium
Measured: From signing ICF to 10 days after last dose.
Serum calcium
Measured: From signing ICF to 10 days after last dose.
Serum total bilirubin
Measured: From signing ICF to 10 days after last dose.
Serum cholesterol
Measured: From signing ICF to 10 days after last dose.
Serum triglycerides
Measured: From signing ICF to 10 days after last dose.
Serum creatinine
Measured: From signing ICF to 10 days after last dose.
Serum uric acid
Measured: From signing ICF to 10 days after last dose.
Serum creatine phosphokinase (CPK)
Measured: From signing ICF to 10 days after last dose.
Serum gamma glutamyl transferase (GGT
Measured: From signing ICF to 10 days after last dose.
White blood cell (WBC) count
Measured: From signing ICF to 10 days after last dose.
Neutrophils (percentage and absolute count)
Measured: From signing ICF to 10 days after last dose.
Red blood cell (RBC) count
Measured: From signing ICF to 10 days after last dose.
Lymphocytes (percentage）
Measured: From signing ICF to 10 days after last dose.
Lymphocytes (absolute count)
Measured: From signing ICF to 10 days after last dose.
Hemoglobin (Hb)
Measured: From signing ICF to 10 days after last dose.
Monocytes (percentage)
Measured: From signing ICF to 10 days after last dose.
Monocytes (absolute count)
Measured: From signing ICF to 10 days after last dose.
Hematocrit (HCT)
Measured: From signing ICF to 10 days after last dose.
Eosinophils (percentage)
Measured: From signing ICF to 10 days after last dose.
Eosinophils (absolute count)
Measured: From signing ICF to 10 days after last dose.
Mean corpuscular volume (MCV)
Measured: From signing ICF to 10 days after last dose.
Basophils (percentage)
Measured: From signing ICF to 10 days after last dose.
Basophils (absolute count)
Measured: From signing ICF to 10 days after last dose.
Mean corpuscular hemoglobin (MCH)
Measured: From signing ICF to 10 days after last dose.
Platelet count
Measured: From signing ICF to 10 days after last dose.
Mean corpuscular hemoglobin concentration (MCHC)
Measured: From signing ICF to 10 days after last dose.
RBC distribution width
Measured: From signing ICF to 10 days after last dose.
Urine bilirubin
Measured: From signing ICF to 10 days after last dose.
Urine blood
Measured: From signing ICF to 10 days after last dose.
Urine glucose
Measured: From signing ICF to 10 days after last dose.
Urine PH
Measured: From signing ICF to 10 days after last dose.
Urine specific gravity
Measured: From signing ICF to 10 days after last dose.
Urine ketones
Measured: From signing ICF to 10 days after last dose.
Urine protein
Measured: From signing ICF to 10 days after last dose.
Urine leukocytes
Measured: From signing ICF to 10 days after last dose.
Urine urobilinogen
Measured: From signing ICF to 10 days after last dose.
Urine nitrite
Measured: From signing ICF to 10 days after last dose.
Urine microscopic (only for abnormal urine stick test findings).
Measured: From signing ICF to 10 days after last dose.
Supine BP
Measured: From signing ICF to 10 days after last dose.
Pulse
Measured: From signing ICF to 10 days after last dose.
Body temperature
Measured: From signing ICF to 10 days after last dose.
Respiratory rate
Measured: From signing ICF to 10 days after last dose.
ECG PR interval
Measured: From signing ICF to 10 days after last dose.
ECG QRS interval
Measured: From signing ICF to 10 days after last dose.
ECG RR interval
Measured: From signing ICF to 10 days after last dose.
ECG QT interval
Measured: From signing ICF to 10 days after last dose.
ECG QT interval corrected for heart rate (QTc)
Measured: From signing ICF to 10 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start9 Oct 2020
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Everstar Medicines (Shanghai) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haiyan Li, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613999
- Sponsor's protocol ID
- ES102102
- Status last verified
- Jan 2024
- First submitted
- 30 Sep 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04613999
- Acronym / sponsor ID
- ES102102
- Conditions
- Healthy Volunteer, Pharmacokinetic Study
- Keywords
- Healthy volunteer, Pharmacokinetic, safety and tolerability, Ralinepag
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Everstar Medicines (Shanghai) LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, open-label, fixed sequence, non-randomized study of healthy subjects. The study is planned to enroll 15 subjects to ensure data for 8 evaluable subjects.
Subjects will visit the clinical unit for a screening visit up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit prior to investigational medicinal product (IMP) administration (Day -1) and will remain onsite through the study discharge on Day 19. Following an overnight fast of at least 8 hours, 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. Ralinepag (APD811) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: RalinepagSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 1. Healthy subjects aged 18 to 45 years at the time of signing the informed consent form (ICF).
- 2. Body mass index of 19.0 to 25.0 kg/m2.
- 3. 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).
- 4. HIV, Syphilitics, Hepatitis B and Hepatitis C negative at the screening evaluation.
- 5. Adequate venous access in the left or right arm to allow for collection of a number of blood samples
Key exclusion criteria (23 listed)
- 1. History or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma), which is allowed.
- 2. History or presence of any clinically significant psychiatric condition (including depression or prior suicidal behaviour).
- 3. Evidence of clinically relevant medical illness, cardiovascular, hematological, gastrointestinal, hepatic, renal, rheumatologic, endocrine, pulmonary, neurologic, psychiatric or skin disorder (excluding skin cancer as described in Exclusion Criterion 1) or history of hypertension or heart disease including any abnormal laboratory results deemed clinically significant by the study investigator at screening.
- 4. History of dysphagia.
- 5. Clinically significant surgical procedure or traumatic injury within 3 months of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RalinepagRalinepag 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. | Drug | Single Arm |
Primary outcome
Cmax
Time frame: Baseline to 96 hours
Maximum concentration determined directly from the concentration-time profile
Tmax
Time frame: Baseline to 96 hours
Time to maximum concentration determined directly from the concentration-time profile
T1/2
Time frame: Baseline to 96 hours
Terminal elimination half-life calculated as: ln2/λz
AUC0-24
Time frame: Baseline to 96 hours
Area under the concentration-time curve (AUC) from pre-dose (time 0) to 24 hours post-dose calculated using the linear-log trapezoidal rule
AUClast
Time frame: Baseline to 96 hours
AUC from time zero to the time of the last quantifiable concentration (Tlast) calculated using the linear-log trapezoidal rule
AUCinf
Time frame: Baseline to 96 hours
AUC from pre-dose (Time 0) extrapolated to infinite time (AUClast + Clast/λz) calculated using the linear-log trapezoidal rule
73 secondary outcomes
Adverse event reporting
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of dermatologic.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of head.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of eyes.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of ears.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of mouth.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of throat.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of neck.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of thyroid.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of lymph nodes.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of respiratory system.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of cardiovascular system.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of gastrointestinal system.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of extremities.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of musculoskeletal system.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of neurologic system.
Time frame: From signing ICF to 10 days after last dose.
Assessment of general appearance of psychiatric system.
Time frame: From signing ICF to 10 days after last dose.
Serum alanine aminotransferase (ALT)
Time frame: From signing ICF to 10 days after last dose.
Serum glucose
Time frame: From signing ICF to 10 days after last dose.
Serum albumin
Time frame: From signing ICF to 10 days after last dose.
Serum lactate dehydrogenase (LDH)
Time frame: From signing ICF to 10 days after last dose.
Serum alkaline phosphatase (ALP)
Time frame: From signing ICF to 10 days after last dose.
Serum phosphorus
Time frame: From signing ICF to 10 days after last dose.
Serum aspartate aminotransferase (AST)
Time frame: From signing ICF to 10 days after last dose.
Serum potassium
Time frame: From signing ICF to 10 days after last dose.
Serum blood urea
Time frame: From signing ICF to 10 days after last dose.
Serum sodium
Time frame: From signing ICF to 10 days after last dose.
Serum calcium
Time frame: From signing ICF to 10 days after last dose.
Serum total bilirubin
Time frame: From signing ICF to 10 days after last dose.
Serum cholesterol
Time frame: From signing ICF to 10 days after last dose.
Serum triglycerides
Time frame: From signing ICF to 10 days after last dose.
Serum creatinine
Time frame: From signing ICF to 10 days after last dose.
Serum uric acid
Time frame: From signing ICF to 10 days after last dose.
Serum creatine phosphokinase (CPK)
Time frame: From signing ICF to 10 days after last dose.
Serum gamma glutamyl transferase (GGT
Time frame: From signing ICF to 10 days after last dose.
White blood cell (WBC) count
Time frame: From signing ICF to 10 days after last dose.
Neutrophils (percentage and absolute count)
Time frame: From signing ICF to 10 days after last dose.
Red blood cell (RBC) count
Time frame: From signing ICF to 10 days after last dose.
Lymphocytes (percentage）
Time frame: From signing ICF to 10 days after last dose.
Lymphocytes (absolute count)
Time frame: From signing ICF to 10 days after last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Li principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ralinepag in people with Healthy Volunteer and Pharmacokinetic Study, run by Everstar Medicines (Shanghai) Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Baseline to 96 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.