HealthyPhase 1NCT04112446
Study to Evaluate Absorption, Metabolism and Excretion of Single-dose [14C]-Saroglitazar in Healthy Male Subjects
A Phase 1 study testing Saroglitazar magnesium in people with Healthy, run by Zydus Therapeutics Inc. at 1 site in United States.
Trial summary
This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saroglitazar magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 29 Oct 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Known hypersensitivity to either saroglitazar magnesium or other PPAR agonists, and/or the excipients in the saroglitazar magnesium formulation.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). History of cholecystectomy will not be allowed.
- Subjects with congenital nonhemolytic hyperbilirubinemia (eg, suspicion of Gilbert's syndrome based on total and direct bilirubin).
- History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
Show all 22Show fewer
- Alcohol consumption of > 14 units per week. One unit of alcohol equals 12 oz (360 mL) of beer, 1½ oz (45 mL) of liquor, or 5 oz (150 mL) of wine.
- Positive urine drug screen at Screening or positive alcohol breath test result or positive urine drug screen at Check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test ( Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing or 5 times the t1/2 (whichever is longer).
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating saroglitazar magnesium, and have previously received the investigational product.
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in.
- Subjects who have participated in a radiolabeled drug study where exposures are known to the Investigator within the previous 4 months prior to admission to the clinic for this study or participated in a radiolabeled drug study where exposures are not known to the Investigator within the previous 6 months prior to admission to the clinic for this study. The total 12-month exposure from this study and a maximum of 2 other previous radiolabeled studies within 4 to 12 months prior to this study will be within the Code of Federal Regulations (CFR) recommended levels considered safe, per United States (US) Title 21 CFR 361.1: less than 5,000 mrem whole-body annual exposure with consideration given to the half-lives of the previous radiolabeled study drugs received.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Saroglitazar Following a Single Oral Dose of [14C]-Saroglitazar Magnesium in Healthy Male Subjects
This will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.
Read the detailed description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1 and be confined to the CRU until at least Day 8. On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections and ≥ 90% mass balance recovery, or ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which both are collected. If discharge criteria are not met by Day 8, subjects will remain in the CRU up to Day 12.
- Conditions
- Healthy
- Being tested
- Saroglitazar magnesium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar magnesiumDrug
Also called not any
On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | 4 mg [14C]-saroglitazar magnesium (approximately 100 μCi) oral suspension Receives: Drug: Saroglitazar magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from time zero to infinity (AUC0-∞)
Area under the time curve from time zero to infinity will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Measured: At predose to maximum up to Day 12
AUC from time zero to the last quantifiable concentration (AUC0-t) administration of [14C]-saroglitazar magnesium
Area under the time curve from time zero to the last quantifiable concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Measured: At predose to maximum up to Day 12
Cmax
Maximum observed concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Measured: At predose to maximum up to Day 12
Tmax
Time to reach maximum observed concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Measured: At predose to maximum up to Day 12
t1/2
Apparent terminal elimination half-life will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Measured: At predose to maximum up to Day 12
Apparent total clearance (CL/F)
The apparent total clearance (CL/F) will be determined for saroglitazar
Measured: At predose to maximum up to Day 12
Apparent volume of distribution (Vz/F) during the terminal elimination phase
The Apparent volume of distribution (Vz/F) during the terminal elimination phase will be determined for saroglitazar
Measured: At predose to maximum up to Day 12
AUC0-∞ of plasma saroglitazar relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma saroglitazar/Total Radioactivity Ratio)
AUC0-∞ of plasma saroglitazar relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma saroglitazar/Total Radioactivity Ratio) will be calculated
Measured: At predose to maximum up to Day 12
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0 ∞ Blood/Plasma Ratio)
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0 ∞ Blood/Plasma Ratio) will be calculated
Measured: At predose to maximum up to Day 12
Mean residence time
Mean residence time for saroglitazar and saroglitazar sulfoxide will be calculated
Measured: At predose to maximum up to Day 12
Total radioactivity amount excreted in urine and feces
Amount of radioactivity excreted in urine and Feces will be calculated.
Measured: At predose to maximum up to Day 12
Percentage radioactivity excreted in urine and feces
Percentage radioactivity excreted in urine and Feces will be calculated.
Measured: At predose to maximum up to Day 12
Renal clearance (CLR)
Renal clearance for saroglitazar and saroglitazar sulfoxide will be determined
Measured: At predose to maximum up to Day 12
Secondary outcomes (2)
Metabolic profile/ identifications of metabolites and probable structure elucidation for saroglitazar in plasma, urine, and feces
Metabolic profile/ identifications of metabolites and probable structure elucidation for saroglitazar in different matrices like plasma, urine, and feces will be performed and reported
Measured: Maximum up to Day 12
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Incidence and severity of AEs as a measure of safety and tolerability will be measured and reported
Measured: Maximum up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start20 Sep 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E. Blanchard, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112446
- Sponsor's protocol ID
- SARO.19.002
- Status last verified
- Nov 2019
- First submitted
- 11 Sep 2019
- Last updated
- 13 Nov 2019
- 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 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Saroglitazar Following a Single Oral Dose of [14C]-Saroglitazar Magnesium in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04112446
- Acronym / sponsor ID
- SARO.19.002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 2 Oct 2019 (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 will be a Phase I, open-label, nonrandomized, single-dose study in healthy male subjects.
Detailed description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1 and be confined to the CRU until at least Day 8. On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium. Subjects will be discharged if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections and ≥ 90% mass balance recovery, or ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which both are collected. If discharge criteria are not met by Day 8, subjects will remain in the CRU up to Day 12.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Drug: Saroglitazar magnesium4 mg [14C]-saroglitazar magnesium (approximately 100 μCi) oral suspension |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by the Investigator (or designee).
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Key exclusion criteria (22 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- Known hypersensitivity to either saroglitazar magnesium or other PPAR agonists, and/or the excipients in the saroglitazar magnesium formulation.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed). History of cholecystectomy will not be allowed.
- Subjects with congenital nonhemolytic hyperbilirubinemia (eg, suspicion of Gilbert's syndrome based on total and direct bilirubin).
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 |
|---|---|---|
| Saroglitazar magnesiumAlso: not anyOn Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium | Drug | Study Treatment |
Primary outcome
AUC from time zero to infinity (AUC0-∞)
Time frame: At predose to maximum up to Day 12
Area under the time curve from time zero to infinity will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
AUC from time zero to the last quantifiable concentration (AUC0-t) administration of [14C]-saroglitazar magnesium
Time frame: At predose to maximum up to Day 12
Area under the time curve from time zero to the last quantifiable concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Cmax
Time frame: At predose to maximum up to Day 12
Maximum observed concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Tmax
Time frame: At predose to maximum up to Day 12
Time to reach maximum observed concentration will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
t1/2
Time frame: At predose to maximum up to Day 12
Apparent terminal elimination half-life will be calculated for saroglitazar and saroglitazar sulfoxide in plasma, and total radioactivity in whole blood and plasma
Apparent total clearance (CL/F)
Time frame: At predose to maximum up to Day 12
The apparent total clearance (CL/F) will be determined for saroglitazar
Apparent volume of distribution (Vz/F) during the terminal elimination phase
Time frame: At predose to maximum up to Day 12
The Apparent volume of distribution (Vz/F) during the terminal elimination phase will be determined for saroglitazar
AUC0-∞ of plasma saroglitazar relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma saroglitazar/Total Radioactivity Ratio)
Time frame: At predose to maximum up to Day 12
AUC0-∞ of plasma saroglitazar relative to AUC0-∞ of plasma total radioactivity (AUC0-∞ Plasma saroglitazar/Total Radioactivity Ratio) will be calculated
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0 ∞ Blood/Plasma Ratio)
Time frame: At predose to maximum up to Day 12
AUC0-∞ of whole blood total radioactivity to AUC0-∞ of plasma total radioactivity (AUC0 ∞ Blood/Plasma Ratio) will be calculated
Mean residence time
Time frame: At predose to maximum up to Day 12
Mean residence time for saroglitazar and saroglitazar sulfoxide will be calculated
Total radioactivity amount excreted in urine and feces
Time frame: At predose to maximum up to Day 12
Amount of radioactivity excreted in urine and Feces will be calculated.
Percentage radioactivity excreted in urine and feces
Time frame: At predose to maximum up to Day 12
Percentage radioactivity excreted in urine and Feces will be calculated.
Renal clearance (CLR)
Time frame: At predose to maximum up to Day 12
Renal clearance for saroglitazar and saroglitazar sulfoxide will be determined
2 secondary outcomes
Metabolic profile/ identifications of metabolites and probable structure elucidation for saroglitazar in plasma, urine, and feces
Time frame: Maximum up to Day 12
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Maximum up to Day 12
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 13 Nov 2019.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
John E. Blanchard, MD principal investigator
Covance
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 Saroglitazar magnesium in people with Healthy, run by Zydus Therapeutics Inc. at 1 site in United States.
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 5 inclusion and 22 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 13 Nov 2019. 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 States. 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?
AUC from time zero to infinity (AUC0-∞) (time frame: At predose to maximum up to Day 12). The study lists 13 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 13 Nov 2019.