Clinical study to evaluatethe safety, tolerability and pharmacokinetics of ZYAN1, a novel PHD-2 Inhibitor,following oral administration in healthy volunteers.

Phase 1

Completed

• Registration Number: CTRI/2016/02/006665
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. Healthy male or female between 18 and 65 years of age.

2. Hemoglobin: Males -12.8 â?? 14.9 g/dL and Females 11.3- 14.9 g/dl.

3. Male subjects must agree to use one of the contraception methods during the study.

4. Body weight > 55 kg and BMI within the range 18 - 30 kg/m2.

5. Capable of giving written informed consent, which includes compliance with protocol.

6. QTc < 450msec.

7. 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.

Exclusion Criteria

1. Presence or history of severe gastrointestinal disease in the last 6 months.

2. Presence or history of renal insufficiency at any time {Serum creatinine more than upper normal limit (UNL)}.

3. Active liver disease and/or liver transaminase greater than 1.5 X UNL.

4. 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).

5. History or presence of significant alcoholism or drug abuse within the past 1 year.

6. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products (more than 10 times per day) and having a positive urine cotinine test at screening and check-in.

7. Difficulty with donating blood.

8. 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.

9. Pulse rate less than 50/minute and more than 100/minute.

10. Any clinically significant laboratory findings during screening.

11. History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening.

12. Major illness and/or major surgery in last 3 months.

13. Volunteers who have participated in any drug research study other than the present trial within past 3 months.

14. Volunteers who have donated one unit (350 ml) of blood in the past 3 months.

15. Use of any over-the-counter (OTC) or prescription medications within the 30 days or 5 half-lives (whichever is longer), prior to receiving study drug.

16. Use of any herbal medicines (eg, St. Johnâ??s wort) and supplements within the 30 days prior to receiving study drug.

17. Strenuous activity (as assessed by the investigator) is prohibited from 2 days prior to admission until discharge from the unit.

18. For gender effect study, female volunteers with following criteria will not be recruited:

-History of pregnancy or lactation in the past 3 months.

-Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures.

-History of less than 1 year of menopause and not using adequate long-term anti-fertility measures.

-Using hormonal contraceptives.

-Using hormone replacement therapy.

-Unable to give assurance for protection against pregnancy for 3 months after the participation in this trial.

-Positive urine pregnancy test on the day of check-in.

-Positive serum β-hCG level at the screening visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified