Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PKs) of ZYDPLA1 Following Oral Administration in Healthy Volunteers

NCT02620592 | Completed Phase 1 DMC

• 1 other identifier: ZYDPLA1 1001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.

Conditions

Diabetes Mellitus

Keywords

Healthy Subject; ZYDPLA1; DPPIV inhibitor; Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability assessed by monitoring adverse events, clinical, laboratory, electrocardiogram, and vital signs examinations.

  14 Days (Plan 1, III, and IV);

• Safety and tolerability assessed by monitoring adverse events, clinical, laboratory, electrocardiogram, and vital signs examinations.

  28 Days (Plan II)

Secondary Outcomes (29)

• Pharmacokinetic assessment: Maximum plasma concentration (Cmax)

  14 Days (Plan I, III, and IV)

• Maximum plasma concentration (Cmax)

  28 Days (Plan II)

• Time to reach maximum plasma concentration (Tmax)

  14 Days (Plan I, III, and IV)

• Time to reach maximum plasma concentration (Tmax)

  28 Days (Plan II)

• Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)

  14 Days (Plan I, III, and IV)

Study Arms (2)

ZYDPLA1 tablet

ACTIVE COMPARATOR

ZYDPLA1 tablets: Route of administration: Oral Dosage (Single Ascending Study): 1 mg, 5mg, 20mg, 50mg, 100mg, 200mg Multiple Ascending Study: 100mg, 200mg Food effect and Gender effect study: 200mg

Drug: ZYDPLA1 tablet

Placebo

PLACEBO COMPARATOR

Placebo tablets: Route of administration: Oral Dosage (Single Ascending Study): 1 mg, 5mg, 20mg, 50mg, 100mg, 200mg Multiple Ascending Study: 100mg, 200mg Food effect and Gender effect study: 200mg

Drug: Placebo tablet

Interventions

ZYDPLA1 tablet DRUG

The oral dose of ZYDPLA1 tablet administered with 240 ± 10 mL of water at ambient temperature.

ZYDPLA1 tablet

Placebo tablet DRUG

The oral dose of placebo tablet administered with 240 ± 10 mL of water at ambient temperature.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female between 18 and 65 years of age.
• Male subjects must agree to use one of the contraception methods during the study. Male contraceptive options include: Vasectomy, Abstinence requiring the use of contraceptives if becoming sexually active, or double barrier method (condom with spermicide, diaphragm or cervical cap). No Sperm donation for at least up to 90 days after last investigational product.
• BMI within the range 18.0 - 30.0 kg/m2 BMI value should be rounded off to one significant digit after decimal point. BMI values should be rounded to the nearest integer (ex. 30.4 rounds down to 30, while 17.5 rounds up to 18).
• Capable of giving written informed consent, which includes compliance with protocol.
• Corrected QT interval (QTc) interval \< 450msec (as measured by QTcF)
• For gender effect study, only females with history of sterility or at least 1 year menopause or use of long acting non hormonal contraceptive measures (e.g., intrauterine device) will be recruited. Surgical sterility is defined as either bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy.
• Negative Urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine within 28 days prior to initiation of the study and prior to check-in.

You may not qualify if:

• Presence or history of pancreatitis at any time {Serum Amylase/Serum Lipase more than significant upper normal limit (≥1.5 times UNL)}
• Presence or history of severe gastrointestinal disease in the last 6 months
• Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL)}
• Active liver disease and/or liver transaminases greater than 1.5 times UNL
• 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)
• History or presence of any medication in the last 14 days
• History or presence of significant alcoholism or drug abuse within the past 1 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 or difficulty in accessibility of veins.
• Intolerance to venipuncture.
• Systolic blood pressure more than 150 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg
• Pulse rate less than 50/minute and more than 100/minute
• Any clinically significant laboratory findings during screening
• History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening as determined by the Principal Investigator.
• Major illness and/or major surgery in last 3 months

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rajendrakumar H Jani, Ph.D.,

  Zydus Lifesciences Limited

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 3, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-11

Locations

US (1)