Healthy SubjectsPhase 1NCT05562362
Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension
A Phase 1 study testing RE-021, sparsentan in people with Healthy Subjects, run by Travere Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- RE-021, sparsentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2020to 12 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or healthy females of non-childbearing potential
- Between 18 and 55 years of age, inclusive, at time of signing informed consent
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must agree to adhere to the contraception requirements
Who cannot join
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Subjects who are or are immediate family members of a study site employee or a sponsor employee
- Subjects who have previously been enrolled (dosed) in this study; subjects who have previously received sparsentan
- Evidence current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
Show all 35Show fewer
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 3 months
- A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 3 months
- Females of childbearing potential:
- A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration ≥40 IU/L)
- Subjects who are pregnant or lactating and subjects with pregnant or lactating partners. All women must have a negative pregnancy test at admission
- Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening
- Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator at screening
- Serum alanine aminotransferase (ALT) > 1.5× upper limit of normal at screening
- Serum potassium > upper limit of normal at screening
- Confirmed positive drugs of abuse test result at screening or admission to Period 1
- Corrected QT interval by Fridericia's formula (QTcF) greater than 450 msec; ventricular rate less than 40 per minute or greater than 90 per minute at screening or prior to dosing
- For supine vital signs: systolic blood pressure less than 100 mmHg or greater than 140 mmHg (in subjects > 45 years of age up to 160 mmHg is acceptable); diastolic blood pressure less than 60 mmHg or over 90 mmHg at screening and pre-first dose.
- Decrease in systolic blood pressure of 20 mmHg or more and/or decrease in diastolic blood pressure of 10 mmHg or more, measured after standing for approximately 2 to 5 min at screening and pre-dose in Period 1.
- Increase in heart rate of over 30 bpm measured after standing for 2 to 5 min at screening and pre-dose Period 1
- Any current or recent symptoms of postural hypotension or postural tachycardia at screening and pre-dose Period 1
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an eGFR of <90 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) (2009) equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of cholecystectomy or gall stones
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Subjects with a history of any hypersensitivity to angiotensin receptor blockers, endothelin receptor antagonists or the suspension formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than 4 g of paracetamol per day or hormone replacement therapy [HRT]) in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the PI
- Use of any medication, eg erythromycin, itraconazole, and gestodene, that is known to inhibit CYP3A4 within 14 days before IMP administration
- Use of any medication or substance known to induce CYP3A4, eg St John's Wort, within 30 days before IMP administration
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three Way Sequential, Randomised, Open-Label Study Designed to Evaluate the Single and Multiple-Dose Pharmacokinetics and the Effect of Food on the Single-Dose Pharmacokinetics of Oral Sparsentan Suspension in Healthy Subjects
This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels. In each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess Pharmacokinetics (PK) following multiple dosing.
Read the detailed description
This is a single-center, open-label, randomized, single- and multiple-dose, 3-way sequential study at 3 dose levels in healthy subjects. For logistical purposes subjects will be admitted to the unit to be dosed in groups of approximately 16 or fewer. Subjects will be randomized into one of the three dose levels. Within each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess PK following multiple dosing.
Subjects will undergo preliminary screening procedures for the study at the screening visit (Day -28 to Day -2). Subjects will be admitted to the clinical unit on the evening prior to investigational medicinal product (IMP) administration (Day -1) and will remain on site until 72 h post-final dose. Subjects will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study day 1) and a single dose of sparsentan in the fed state (high-fat breakfast) on Period 2, Day 1 (Study day 8), followed by multiple doses of sparsentan in the fed state on Period 3, Day 1 to 14 (Study days 12 to 25). On PK sampling days for the multiple dose treatment period (Period 3, Days 7, and 14; Study days 18 and 25), subjects will consume a high-fat breakfast before dosing; on other days, a standard breakfast will be provided.
A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the subjects.
- Conditions
- Healthy Subjects
- Being tested
- RE-021, sparsentan
- Keywords
- Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A Nephropathy (IgAN)
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE-021, sparsentanDrug
RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level
| Study group | Role | What they receive |
|---|---|---|
| Fasted State | Experimental | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will be randomized to 1 of 3 dose levels (200mg, 400mg and 800 mg) and will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study Day 1) Receives: Drug: RE-021, sparsentan |
| Fed State | Experimental | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have a single dose of sparsentan (200mg, 400mg and 800 mg) in the fed state (high-fat breakfast) on Period 2, Day 1 (Study Day 8) Receives: Drug: RE-021, sparsentan |
| Fed State - Multiple | Experimental | Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have multiple doses of sparsentan (200mg, 400mg and 800 mg) in the fed state on Period 3, Days 1 to 14 (Study days 12 to 25) Receives: Drug: RE-021, sparsentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - Cmax
Evaluation of, at minimum, the maximum concentration (Cmax) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Measured: Study Days 1 and 8
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - AUC(0-last)
Evaluation of, at minimum, the area under the concentration-time curve from dosing time 0 (AUC(0-last)) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Measured: Study Days 1 and 8
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted - states - AUC(0-inf)
Evaluation of, at minimum, the area under the concentration curve to infinite (AUC(0-inf)) time parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Measured: Study Days 1 and 8
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat - breakfast - Cmax
Evaluation of the ratio, fed/fasted, for the Cmax
Measured: Study Days 1 and 8
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat - breakfast - AUC(0-last)
Evaluation of the ratio, fed/fasted, for the AUC(0-last)
Measured: Study Days 1 and 8
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat breakfast - AUC(0-inf)
Evaluation of the ratio, fed/fasted, for the AUC(0-inf)
Measured: Study Days 1 and 8
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - Cmax
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Cmax from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Measured: Study Days 12 to 28
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - AUC(0-24)
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Area under the plasma concentration-time curve over the last 24-h dosing interval (AUC(0-24)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Measured: Study Days 12 to 28
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - TCP (AUC(0-24)/AUC(0-inf)
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: temporal change parameter (TCP) (AUC(0-24)/AUC(0-inf)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Measured: Study Days 12 to 28
Secondary outcomes (6)
Assessment of safety and tolerability of sparsentan oral suspension - clinical chemistry, hematology and eGFR
Safety laboratory tests including clinical chemistry, hematology and estimated glomerular filtration rate (eGFR) at each time point including virology and follicle stimulating hormone (FSH) (post-menopausal female subjects only) at screening
Measured: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - vital sign (blood pressure)
Supine systolic and diastolic blood pressure (BP), including change from the baseline (Day 1, Pre-dose of each study period) will be summarized (ie, n -number of subjects with an observation, mean, SD - standard deviation, median, minimum and maximum) at each post-baseline time point by regimen. The number of subjects with 'substantial' increases or decreases or no substantial change from baseline in systolic BP (>20 mmHg), diastolic BP (>10 mmHg) will be summarized.
Measured: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - vital sign (heart rate)
Supine heart rate, including change from the baseline (Day 1, Pre-dose of each study period) will be summarized (ie, n -number of subjects with an observation, mean, SD - standard deviation, median, minimum and maximum) at each post-baseline time point by regimen. The number of subjects with 'substantial' increases or decreases or no substantial change from baseline in heart rate (>15 bpm) will be summarized.
Measured: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - ECG
Electrocardiogram (ECG) data, including change from baseline (Day 1, Pre-dose of each study period), will be summarized (ie, n -number of subjects with an observation, mean, SD - standard deviation, median, minimum and maximum)) at each post-baseline time point by regimen. The number and percentage of subjects with normal and prolonged QT intervals corrected for heart rate using Fridericia's correction (QTcF) and increases in QTcF intervals from baseline within the categories, defined as QTcF interval <=450 millisecond (msec), 451-480 msec, 481-500 msec, >500 msec, increase in QTcF interval from baseline <30 msec, 30-60 msec, >60 msec (based on the International Council on Harmonization [ICH] E14 guideline ) will be summarized at each post-baseline time point by regimen and time point.
Measured: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - AEs
An AE is any untoward medical occurrence in a subject that occurs either before dosing (referred to as a pre-dose AE) or once a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. Treatment-emergent adverse events (TEAEs) are AEs that commence during/after the first dose of investigational medicinal product (IMP) or commence before first dose of IMP (ie, a pre-dose AE or existing medical condition) but worsen in intensity during exposure to IMP. The number and percentage of subjects reporting each TEAE will be summarized for both System Organ Class (SOC) and Preferred Term (PT). For summaries by SOC and PT, with the exception of TEAEs by severity and relationship to IMP, the number of subjects and the number of events will be summarized. For summaries by severity and relationship only the number of subjects will be summarized.
Measured: 2 to 28 days before Study Day 1 until 5 to 7 days post-final dose
Acceptability and key taste attributes of sparsentan oral suspension
Assess the palatability of the oral suspension using the results from a 9-point scale that rate acceptability of smell, sweetness, bitterness, flavor, mouth feel/texture, grittiness and aftertaste, and overall acceptability for a single dose of an oral suspension of sparsentan in the fasted state. Patient will rate overall liking of the product from a 9-point scale ranging from 1 = Dislike extremely and 9 = Like extremely.
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start18 Jun 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Travere Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562362
- Sponsor's protocol ID
- RTRX-RE021-102 (QSC200850)
- Status last verified
- Jun 2022
- First submitted
- 23 Aug 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three Way Sequential, Randomised, Open-Label Study Designed to Evaluate the Single and Multiple-Dose Pharmacokinetics and the Effect of Food on the Single-Dose Pharmacokinetics of Oral Sparsentan Suspension in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05562362
- Acronym / sponsor ID
- RTRX-RE021-102 (QSC200850)
- Conditions
- Healthy Subjects
- Keywords
- Focal Segmental Glomerulosclerosis (FSGS), Immunoglobulin A Nephropathy (IgAN)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Travere Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 30 Sep 2022 (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.
This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels. In each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess Pharmacokinetics (PK) following multiple dosing.
Detailed description
This is a single-center, open-label, randomized, single- and multiple-dose, 3-way sequential study at 3 dose levels in healthy subjects. For logistical purposes subjects will be admitted to the unit to be dosed in groups of approximately 16 or fewer. Subjects will be randomized into one of the three dose levels. Within each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess PK following multiple dosing.
Subjects will undergo preliminary screening procedures for the study at the screening visit (Day -28 to Day -2). Subjects will be admitted to the clinical unit on the evening prior to investigational medicinal product (IMP) administration (Day -1) and will remain on site until 72 h post-final dose. Subjects will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study day 1) and a single dose of sparsentan in the fed state (high-fat breakfast) on Period 2, Day 1 (Study day 8), followed by multiple doses of sparsentan in the fed state on Period 3, Day 1 to 14 (Study days 12 to 25). On PK sampling days for the multiple dose treatment period (Period 3, Days 7, and 14; Study days 18 and 25), subjects will consume a high-fat breakfast before dosing; on other days, a standard breakfast will be provided.
A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fasted State | Experimental | Drug: RE-021, sparsentanSparsentan will be administered in 3-dose level in healthy subjects. Subjects will be randomized to 1 of 3 dose levels (200mg, 400mg and 800 mg) and will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study Day 1) |
| Fed State | Experimental | Drug: RE-021, sparsentanSparsentan will be administered in 3-dose level in healthy subjects. Subjects will have a single dose of sparsentan (200mg, 400mg and 800 mg) in the fed state (high-fat breakfast) on Period 2, Day 1 (Study Day 8) |
| Fed State - Multiple | Experimental | Drug: RE-021, sparsentanSparsentan will be administered in 3-dose level in healthy subjects. Subjects will have multiple doses of sparsentan (200mg, 400mg and 800 mg) in the fed state on Period 3, Days 1 to 14 (Study days 12 to 25) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or healthy females of non-childbearing potential
- Between 18 and 55 years of age, inclusive, at time of signing informed consent
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 as measured at screening
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
Key exclusion criteria (35 listed)
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Subjects who are or are immediate family members of a study site employee or a sponsor employee
- Subjects who have previously been enrolled (dosed) in this study; subjects who have previously received sparsentan
- Evidence current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
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 |
|---|---|---|
| RE-021, sparsentanRE-021, sparsentan - Subjects will be randomized 1 of 3 dose level | Drug | Fasted State, Fed State, Fed State - Multiple |
Primary outcome
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - Cmax
Time frame: Study Days 1 and 8
Evaluation of, at minimum, the maximum concentration (Cmax) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - AUC(0-last)
Time frame: Study Days 1 and 8
Evaluation of, at minimum, the area under the concentration-time curve from dosing time 0 (AUC(0-last)) parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted - states - AUC(0-inf)
Time frame: Study Days 1 and 8
Evaluation of, at minimum, the area under the concentration curve to infinite (AUC(0-inf)) time parameters for sparsentan following a single dose of sparsentan as an oral suspension in the fed or fasted state.
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat - breakfast - Cmax
Time frame: Study Days 1 and 8
Evaluation of the ratio, fed/fasted, for the Cmax
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat - breakfast - AUC(0-last)
Time frame: Study Days 1 and 8
Evaluation of the ratio, fed/fasted, for the AUC(0-last)
Food effect on pharmacokinetics of sparsentan oral suspension dosed after standard high-fat breakfast - AUC(0-inf)
Time frame: Study Days 1 and 8
Evaluation of the ratio, fed/fasted, for the AUC(0-inf)
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - Cmax
Time frame: Study Days 12 to 28
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Cmax from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - AUC(0-24)
Time frame: Study Days 12 to 28
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: Area under the plasma concentration-time curve over the last 24-h dosing interval (AUC(0-24)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
Multiple-dose pharmacokinetics of a sparsentan oral suspension dosed in the fed state - TCP (AUC(0-24)/AUC(0-inf)
Time frame: Study Days 12 to 28
Evaluation of, at minimum, the following pharmacokinetics parameters for sparsentan following multiple doses of sparsentan as an oral suspension in the fed state: temporal change parameter (TCP) (AUC(0-24)/AUC(0-inf)) from a single dose for Study days 18 and 25 (Period 3, Days 7 and 14)
6 secondary outcomes
Assessment of safety and tolerability of sparsentan oral suspension - clinical chemistry, hematology and eGFR
Time frame: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - vital sign (blood pressure)
Time frame: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - vital sign (heart rate)
Time frame: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - ECG
Time frame: Study Days 1 to 28
Assessment of Safety and tolerability of sparsentan oral suspension - AEs
Time frame: 2 to 28 days before Study Day 1 until 5 to 7 days post-final dose
Acceptability and key taste attributes of sparsentan oral suspension
Time frame: Study Day 1
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 30 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 RE-021, sparsentan in people with Healthy Subjects, run by Travere Therapeutics, Inc. at 1 site in United Kingdom.
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 6 inclusion and 35 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 30 Sep 2022. 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 United Kingdom. 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?
Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - Cmax (time frame: Study Days 1 and 8). The study lists 9 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 30 Sep 2022.