ObesityPhase 1NCT01543269
A Clinical Study to Evaluate the Safety,Tolerability and PK of ZYT1, Following Oral Administration in Healthy Volunteers
A Phase 1 study testing ZYT1 in people with Obesity and Lipid Disorders, run by Zydus Lifesciences Limited at 1 site in India.
Trial summary
This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers. The study shall be divided into four plans as given below: 1. Plan I: Single dose escalation trial 2. Plan II: Multiple dose escalation trial 3. Plan III: Food effect trial. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Lipid Disorders
- What is being tested?
- ZYT1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2010to Jul 2012
- 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
- Age: 18-45 years
- Mentally, physically and legally eligible to give informed consent.
- Male and female volunteers weighing between 50-75kg and 45-75kg respectively.
- Ability to communicate effectively with the study personnel.
- Willingness to adhere to the protocol requirements.
- Normal Thyroid Function Tests (free and total T3, free and total T4 and TSH)
- Lipid criteria: Low density lipoprotein (LDL) cholesterol up to 160mg/dL and triglyceride (TG) level up to 500mg/dL
- For gender effect study, only females with history of sterility or one year menopause or use of long acting nonhormonal contraceptive measures (e.g., Intra uterine device) will be recruited.
Who cannot join
- Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYT1 formulation.
- History of thyroid disorders (any form) within 24 weeks prior to the recruitment in the study.
- Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal (ULN).
- Renal insufficiency (serum creatinine > 1.5mg/dL).
- History of myocarditis, hypertrophic cardiomyopathy, valvular heart disease, restrictive cardiomyopathy, constrictive pericarditis, myocardial infarction, ischemic heart disease, stroke, congestive heart failure, cardiac arrhythmia or coronary revascularization procedure at any time.
- Subject who has corrected QT interval (QTc)³ 450 (male) or 470 (female).
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- History or presence of musculoskeletal disorders (e.g., myopathies, myolysis, fractures due to osteoporosis, etc.)
- History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
- Subjects taking other hormonal therapies e.g., glucocorticoids, androgens or growth hormones.
- Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry.
- History of coagulopathy or use of anticoagulants such as warfarin.
- History or presence of chronic medications or any medications in the last 14 days.
- History or presence of significant alcoholism or drug abuse within the past one-year.
- History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day).
- Difficulty with donating blood.
- Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg.
- Pulse rate less than 60/minute and more than 100/minute.
- Any clinically significant abnormal X-ray or laboratory findings during screening.
- History or presence of any clinically significant ECG abnormalities during screening.
- Major illness and/or Major surgery in last 3 months.
- Volunteers who have participated in any drug research study other than the present trial within past 3 months.
- Volunteers who have donated one unit (350ml) of blood in the past 3 months.
- For gender effect study, female volunteers with following criteria will not be recruited:
- History of pregnancy or lactation in the past 3 months b- Fertile female volunteers not protected against pregnancy by adequate long-term anti- fertility device or history of less than one year of menopause
- Using hormonal contraceptives
- Using hormone replacement therapy
- Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial
- History of osteoporosis or history of fracture in the past 6 months
- Positive urine pregnancy test on the day of check-in.
Trial locations and contacts
1 site in 1 country.
India1 site
Zydus Research Centre, Cadila Healthcare Limited
Ahmedabad, Gujarat, 382213
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYT1, a Selective Thyroid Receptor (TR) ß Agonist, Following the Oral Administrations in Healthy Volunteers.
This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers.
The study shall be divided into four plans as given below:
- Plan I: Single dose escalation trial
- Plan II: Multiple dose escalation trial
- Plan III: Food effect trial.
- Plan IV: Gender Effect trial.
The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
Read the detailed description
This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers.
The study is divided into four plans as given below:
- Plan I: Single dose escalation trial: A study is to evaluate safety, tolerability and PK of ZYT1 in healthy volunteers.
- Plan II: Multiple dose escalation trial: A study is to evaluate safety, tolerability, PK and, if demonstrated, capture the Pharmacodynamics of ZYT1 in healthy volunteers.
- Plan III: Food effect trial Effect of food on pharmacokinetics will be studied in a cross over study, with selected dose and based on limit of detection of the investigational medicinal product (IMP) in analytical methods.
- Plan IV: Gender Effect trial . The gender effect study will be conducted after the completion of Panel S5 of single dose safety and tolerability study
The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
- Conditions
- Obesity, Lipid Disorders
- Being tested
- ZYT1, Placebo tablets
- Keywords
- Obesity, Lipid disorders
- Medical subject headings
- Obesity, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZYT1Drug
Also called ZYT1 is expected to demonstrate antidyslipidemic effect and possible wt. reduction through its selective TR β agonistic activity.
Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
Placebo tabletsDrug
Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
| Study group | Role | What they receive |
|---|---|---|
| ZYT1 tablets | Active comparator | ZYT1 tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg Receives: Drug: ZYT1 |
| Placebo | Placebo comparator | Placebo tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ZYT1 (Plan I-IV)
Safety and tolerability for Plan I, II,III and IV (Time Frame upto 14 days) The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
Safety will be assessed by noting the number of subjects who will develop Adverse Event (AE) along with severity and causality assessment.
Measured: 14 Days
Secondary outcomes (1)
Pharmacokinetics (PK) (Plan I, II, III, IV) and pharmacodynamics (PD)(Plan II)
PK parameters:
Plan I, III, IV:Cmax, Tmax, Area Under the Curve (AUC)0-t, AUC 0-inf, T1/2, λz, Clearance (CL), Vd Plan II:Cmin, Tmin, Cavg, % Fluctuation, Accumulation Index, Clss, Cmax, volume of distribution (VZ) or Vss For urine data (Plan I, II, III, IV):Amount recovered, recovered
PD Parameters assessed include Bld glucose, TG, Total Chol., HDL, LDL, very low-density lipoprotein (VLDL), free fatty acid (FFA), Lipoprotein (a), Wt reduction, if any, after Plan II.
Values compared for pre Rx and post Rx levels. PD Analysis made for differences among Rx groups as well as comparing Rx group with placebo.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydus Lifesciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajendrakumar H Jani, PhD(Medical), Study director, Zydus Research Centre, Cadila Healthcare Limited,Moriya, Ahmedabad-382213, Gujrat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543269
- Sponsor's protocol ID
- ZYT1/1001
- Other IDs
- CTRI/2008/091/000256
- Status last verified
- Nov 2015
- First submitted
- 21 Feb 2012
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ZYT1, a Selective Thyroid Receptor (TR) ß Agonist, Following the Oral Administrations in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01543269
- Acronym / sponsor ID
- ZYT1/1001
- Conditions
- Obesity, Lipid Disorders
- Keywords
- Obesity, Lipid disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zydus Lifesciences LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Mar 2012 (estimated)
- 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 is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers.
The study shall be divided into four plans as given below:
- Plan I: Single dose escalation trial
- Plan II: Multiple dose escalation trial
- Plan III: Food effect trial.
- Plan IV: Gender Effect trial.
The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
Detailed description
This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers.
The study is divided into four plans as given below:
- Plan I: Single dose escalation trial: A study is to evaluate safety, tolerability and PK of ZYT1 in healthy volunteers.
- Plan II: Multiple dose escalation trial: A study is to evaluate safety, tolerability, PK and, if demonstrated, capture the Pharmacodynamics of ZYT1 in healthy volunteers.
- Plan III: Food effect trial Effect of food on pharmacokinetics will be studied in a cross over study, with selected dose and based on limit of detection of the investigational medicinal product (IMP) in analytical methods.
- Plan IV: Gender Effect trial . The gender effect study will be conducted after the completion of Panel S5 of single dose safety and tolerability study
The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZYT1 tablets | Active comparator | Drug: ZYT1ZYT1 tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg |
| Placebo | Placebo comparator | Drug: Placebo tabletsPlacebo tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age: 18-45 years
- Mentally, physically and legally eligible to give informed consent.
- Male and female volunteers weighing between 50-75kg and 45-75kg respectively.
- Ability to communicate effectively with the study personnel.
- Willingness to adhere to the protocol requirements.
Key exclusion criteria (29 listed)
- Presence or history of hypersensitivity to any of the active or inactive ingredients of ZYT1 formulation.
- History of thyroid disorders (any form) within 24 weeks prior to the recruitment in the study.
- Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal (ULN).
- Renal insufficiency (serum creatinine > 1.5mg/dL).
- History of myocarditis, hypertrophic cardiomyopathy, valvular heart disease, restrictive cardiomyopathy, constrictive pericarditis, myocardial infarction, ischemic heart disease, stroke, congestive heart failure, cardiac arrhythmia or coronary revascularization procedure at any time.
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 |
|---|---|---|
| ZYT1Also: ZYT1 is expected to demonstrate antidyslipidemic effect and possible wt. reduction through its selective TR β agonistic activity.Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature. | Drug | ZYT1 tablets |
| Placebo tabletsOral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature. | Drug | Placebo |
Primary outcome
Safety and tolerability of ZYT1 (Plan I-IV)
Time frame: 14 Days
Safety and tolerability for Plan I, II,III and IV (Time Frame upto 14 days) The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters. Safety will be assessed by noting the number of subjects who will develop Adverse Event (AE) along with severity and causality assessment.
1 secondary outcome
Pharmacokinetics (PK) (Plan I, II, III, IV) and pharmacodynamics (PD)(Plan II)
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Rajendrakumar H Jani, PhD(Medical) study director
Zydus Research Centre, Cadila Healthcare Limited,Moriya, Ahmedabad-382213, Gujrat, India
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 ZYT1 in people with Obesity and Lipid Disorders, run by Zydus Lifesciences Limited 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 29 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: stopped early, as of the sponsor's last update on 24 Nov 2015. 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 was stopped early (reason given: Safety concerns). Results are not available in the source record.
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?
Safety and tolerability of ZYT1 (Plan I-IV) (time frame: 14 Days). 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 24 Nov 2015.