A Clinical Study to Evaluate the Safety,Tolerability and PK of ZYT1, Following Oral Administration in Healthy Volunteers

NCT01543269 | Terminated Phase 1 DMC

• 2 other identifiers: ZYT1/1001CTRI/2008/091/000256
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 1.Plan I: Single dose escalation trial
2. 2.Plan II: Multiple dose escalation trial
3. 3.Plan III: Food effect trial.
4. 4.Plan IV: Gender Effect trial.

Conditions

Obesity; Lipid Disorders

Keywords

Obesity; Lipid disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  14 Days

Secondary Outcomes (1)

• Pharmacokinetics (PK) (Plan I, II, III, IV) and pharmacodynamics (PD)(Plan II)

  14 days

Study Arms (2)

ZYT1 tablets

ACTIVE COMPARATOR

ZYT1 tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg

Drug: ZYT1

Placebo

PLACEBO COMPARATOR

Placebo tablets: Route of administration: Oral Dosage: 0.5mg, 1mg, 2 mg, 4mg, 8 mg, 16mg, 32mg and 64mg

Drug: Placebo tablets

Interventions

ZYT1 DRUG

Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.

Also known as: ZYT1 is expected to demonstrate antidyslipidemic effect and possible wt. reduction through its selective TR β agonistic activity.

ZYT1 tablets

Placebo tablets DRUG

Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Zydus Research Centre, Cadila Healthcare Limited

Ahmedabad, Gujarat, 382213, India

Location

MeSH Terms

Conditions

Obesity; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Study Officials

• Rajendrakumar H Jani, PhD(Medical)

  Zydus Research Centre, Cadila Healthcare Limited,Moriya, Ahmedabad-382213, Gujrat, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 2, 2012
• Study Start: February 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

IN (1)