HealthyPhase 1NCT04045769
A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
A Phase 1 study testing Saroglitazar magnesium 4mg, Moxifloxacin 400mg and Saroglitazar magnesium 20 mg in people with Healthy, run by Zydus Therapeutics Inc. at 1 site in India.
Trial summary
A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Saroglitazar magnesium 4mg, Moxifloxacin 400mg and Saroglitazar magnesium 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIndia
- Study dates
- 19 Aug 2019to 2 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated written informed consent prior to any study-specific procedures
- Willing and able to comply with the study procedures, restrictions, and requirements.
- At least (≥) 18 years of age and no more than (≤) 45 years of age a
- Body mass index of 19.0 to 25.0 kg/m² (inclusive) with a body weight of 50 to 100 kg
- non-smokers and must not drink alcohol (teetotal).
- Subjects who, in the opinion of the Investigator, are healthy as determined by their pre-study medical history, physical examination, and 12-lead ECG, and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: hematology, serum biochemistry, urinalysis, and serology.
- Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after their last administration of study treatment.
- Systemic blood pressure with a systolic blood pressure of 100 to 140 mmHg and a diastolic blood pressure of 60 to 90 mmHg.
Who cannot join
- History of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.
- A prolongation of the QT interval corrected for HR using Fridericia's correction (QTcF) interval (eg, repeated demonstration of a QTcF interval >450 msec) before study treatment administration.
- Any clinically important abnormalities in the ECG at screening, check-in (Day -1), or predose on Day 1. This includes subjects with any of the following:
- PR interval >210 msec;
- QRS >110 msec; or
- HR <45 beats per minute (bpm) or >100 bpm.
Show all 37Show fewer
- A QRS and/or T-wave value that the Investigator judges to be unfavorable for consistently accurate QT measurements (eg, indistinct QRS onset, low amplitude T-wave, inverted or terminally-inverted T-wave, merged T/U-waves, indistinct T-wave offset, or prominent U-wave that affects QT measurement).
- History of additional risk factors for Torsades de Pointes or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (≤40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child).
- Use of medications in the 90 days before Day -1 of Period 1 that are known to prolong the QT/QTc interval.
- Has used prescription drugs and other substances (eg, dietary or herbal supplements such as St John's Wort) known to be either significant enzyme inducers or enzyme inhibitors within 4 weeks of Day 1 of Period 1, or use of grapefruit or similar substances (Seville oranges or marmalade, grapefruit juice, grapefruit hybrids, pomelos, exotic citrus fruits or fruit juices) within 7 days of Day 1 of Period 1.
- Has used prescription or over-the-counter medication, excluding routine vitamins but including megadose vitamin therapy (intake of 20 to 600 times the recommended daily dose), within 7 days of Day 1 of Period 1, unless agreed as not clinically relevant by the Investigator and Sponsor.
- Any history of malignant disease, including solid tumors, hematologic malignancies, and including any carcinoma in situ.
- Clinically significant allergies, as determined by the Investigator.
- History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
- History of unexplained syncopal or hypotensive episodes.
- A positive cotinine test and positive breath test at screening or check-in (Day -1) of Period 1.
- Surgery within 12 months prior to check-in (Day -1) of Period 1 (other than minor cosmetic surgery and minor dental surgery).
- Subjects who have recent illness (eg, fever >38°C) within 7 days of check-in (Day -1) of Period 1.
- Clinically significant abnormal hematology and serum biochemistry values, as determined by the Investigator or any of the following values at screening or check-in (Day -1) of Period 1:
- Alanine aminotransferase, aspartate aminotransferase, or creatinine above their reference range.
- Hemoglobin or platelets below their reference range.
- Subjects with an absolute neutrophil count <2.0 × 10³/μL at screening or check-in (Day -1) of Period 1, any documented laboratory value <1.5 × 10³/μL, or any documented history of neutropenia.
- Subjects with an estimated glomerular filtration rate (as defined by estimation of creatinine clearance using the Modification of Diet in Renal Disease formula) of ≤80 mL/min/1.73m² at screening.
- History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II.
- Treatment with saroglitazar magnesium, or any other PPAR agonist within 90 days prior to Day -1 of Period 1.
- Treatment with another investigational drug or approved therapy for investigational use within 90 days of Day -1 of Period 1 or 5 × the t1/2 (whichever is longer), or the subjects is in follow-up for any other drug, biologic, or device study.
- Current active infection or serious infection (eg, pneumonia, septicemia) within the 90 days prior to Day -1 of Period 1 as determined by the Investigator.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive.
- Known hypersensitivity to either saroglitazar magnesium or other PPAR agonists, and or the excipients in the saroglitazar magnesium tablet formulation.
- Known hypersensitivity to moxifloxacin or other quinolones.
- Blood donation in the past 90 days, or bone marrow or stem cell donor in the past 12 months prior to check-in (Day -1) of Period 1.
- Any disorder that, in the Investigator's opinion, may interfere with study compliance, such as significant mental, nervous disorder or other illness. In making this assessment, the Investigator must refer to the study information provided including the Investigator's Brochure, and the prescribing information for saroglitazar magnesium.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Inability to be venipunctured or tolerate venous puncture.
- Any condition or abnormal baseline findings that in the Investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study.
- Has acute gastrointestinal symptoms at the time of screening or check-in (Day -1) of Period 1 (eg, nausea, vomiting, diarrhea, heartburn).
- Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Read the detailed description
Primary Objective: This is a Phase 1, single-center, blinded (with respect to saroglitazar magnesium and placebo administration), randomized, placebo- and active-controlled, 4-period crossover study to investigate the effect of single therapeutic and supra-therapeutic (5×) doses of saroglitazar magnesium on the corrected QT (QTc) interval in healthy subjects in compliance with the current version of the International Council for Harmonisation E14 Guidelines.
After confirmation of eligibility, 52 subjects (at least 16 will be females) will be randomly assigned to 1 of 4 treatment sequences using a William's design prior to study treatment administration on Day 1 of Period 1. Randomized subjects will receive each of the 4 study treatments across the 4 treatment periods separated by at least a 7-day washout period.
- Conditions
- Healthy
- Being tested
- Saroglitazar magnesium 4mg, Placebos, Moxifloxacin 400mg, Saroglitazar magnesium 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saroglitazar magnesium 4mgDrug
Also called not any
1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally
PlacebosDrug
Also called not any
5 tablets of placebo to be administered orally
Moxifloxacin 400mgDrug
Also called not any
1 tablet of 400 mg Moxifloxacin to be administered orally
Saroglitazar magnesium 20 mgDrug
Also called not any
5 tablets of 4 mg Saroglitazar magnesium to be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment 1 | Experimental | Saroglitazar magnesium 4 mg Receives: Drug: Saroglitazar magnesium 4mg |
| Study treatment 2 | Experimental | Saroglitazar magnesium 20 mg Receives: Drug: Saroglitazar magnesium 20 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebos |
| Active Control | Active comparator | Moxifloxacin 400 mg Receives: Drug: Moxifloxacin 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcF change-from-baseline
Linear-mixed model will be used to assess the effect of saroglitazar magnesium on cardiac repolarization on Day 1 to evaluate whether saroglitazar magnesium prolongs the QTcF when orally administered to healthy volunteers
Measured: Pre-dose (-1.0 hr) to 24 hours post dose
Saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and placebo-corrected change-from-baseline QTcF
Quantification of the relationship between saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and QTcF, using concentration-effect modeling
Measured: Pre-dose (-1.0 hr) to 24 hours post dose
Secondary outcomes (1)
Observed and change-from-baseline HR, PR, RR, QRS, and QT and ECG morphological abnormalities
Evaluation of the effect of Saroglitazar magnesium on other ECG parameters (ventricular HR, PR, RR, QRS, QT) and ECG morphological abnormalities
Measured: Pre-dose (-1.0 hr) to 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start19 Aug 2019
- Primary completion27 Nov 2019
- Study completion2 Dec 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Deven V Parmar, MD,FCP, Study director, Zydus Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045769
- Sponsor's protocol ID
- SARO.17.006
- Status last verified
- Apr 2020
- First submitted
- 1 Aug 2019
- Last updated
- 21 Apr 2020
- Results posted
- No
- 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 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04045769
- Acronym / sponsor ID
- SARO.17.006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zydus Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 6 Aug 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.
A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Detailed description
Primary Objective: This is a Phase 1, single-center, blinded (with respect to saroglitazar magnesium and placebo administration), randomized, placebo- and active-controlled, 4-period crossover study to investigate the effect of single therapeutic and supra-therapeutic (5×) doses of saroglitazar magnesium on the corrected QT (QTc) interval in healthy subjects in compliance with the current version of the International Council for Harmonisation E14 Guidelines.
After confirmation of eligibility, 52 subjects (at least 16 will be females) will be randomly assigned to 1 of 4 treatment sequences using a William's design prior to study treatment administration on Day 1 of Period 1. Randomized subjects will receive each of the 4 study treatments across the 4 treatment periods separated by at least a 7-day washout period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Treatment 1 | Experimental | Drug: Saroglitazar magnesium 4mgSaroglitazar magnesium 4 mg |
| Study treatment 2 | Experimental | Drug: Saroglitazar magnesium 20 mgSaroglitazar magnesium 20 mg |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo |
| Active Control | Active comparator | Drug: Moxifloxacin 400mgMoxifloxacin 400 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Provision of signed and dated written informed consent prior to any study-specific procedures
- Willing and able to comply with the study procedures, restrictions, and requirements.
- At least (≥) 18 years of age and no more than (≤) 45 years of age a
- Body mass index of 19.0 to 25.0 kg/m² (inclusive) with a body weight of 50 to 100 kg
- non-smokers and must not drink alcohol (teetotal).
Key exclusion criteria (37 listed)
- History of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.
- A prolongation of the QT interval corrected for HR using Fridericia's correction (QTcF) interval (eg, repeated demonstration of a QTcF interval >450 msec) before study treatment administration.
- Any clinically important abnormalities in the ECG at screening, check-in (Day -1), or predose on Day 1. This includes subjects with any of the following:
- A QRS and/or T-wave value that the Investigator judges to be unfavorable for consistently accurate QT measurements (eg, indistinct QRS onset, low amplitude T-wave, inverted or terminally-inverted T-wave, merged T/U-waves, indistinct T-wave offset, or prominent U-wave that affects QT measurement).
- History of additional risk factors for Torsades de Pointes or the presence of a family history of short QT syndrome, long QT syndrome, sudden unexplained death at a young age (≤40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child).
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 magnesium 4mgAlso: not any1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally | Drug | Study Treatment 1 |
| PlacebosAlso: not any5 tablets of placebo to be administered orally | Drug | Placebo |
| Moxifloxacin 400mgAlso: not any1 tablet of 400 mg Moxifloxacin to be administered orally | Drug | Active Control |
| Saroglitazar magnesium 20 mgAlso: not any5 tablets of 4 mg Saroglitazar magnesium to be administered orally | Drug | Study treatment 2 |
Primary outcome
QTcF change-from-baseline
Time frame: Pre-dose (-1.0 hr) to 24 hours post dose
Linear-mixed model will be used to assess the effect of saroglitazar magnesium on cardiac repolarization on Day 1 to evaluate whether saroglitazar magnesium prolongs the QTcF when orally administered to healthy volunteers
Saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and placebo-corrected change-from-baseline QTcF
Time frame: Pre-dose (-1.0 hr) to 24 hours post dose
Quantification of the relationship between saroglitazar and its metabolite saroglitazar sulfoxide plasma concentrations and QTcF, using concentration-effect modeling
1 secondary outcome
Observed and change-from-baseline HR, PR, RR, QRS, and QT and ECG morphological abnormalities
Time frame: Pre-dose (-1.0 hr) to 24 hours post 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 21 Apr 2020.
- Individual participant dataSharing planned: No
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.
Dr. Deven V Parmar, MD,FCP study director
Zydus Therapeutics Inc.
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 4mg, Moxifloxacin 400mg and Saroglitazar magnesium 20 mg in people with Healthy, run by Zydus Therapeutics Inc. at 1 site in India.
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 8 inclusion and 37 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 21 Apr 2020. 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 India. 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. Some participants in this study may receive a placebo. 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?
QTcF change-from-baseline (time frame: Pre-dose (-1.0 hr) to 24 hours post dose). The study lists 2 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 21 Apr 2020.