A study to determine the safety, tolerability and pharmacokinetics of ZYAN1 following oral administration in healthy volunteers.

Phase 1

Recruiting

• Conditions: Anemia; Hypoxia related disorders; Blood - Anaemia

• Registration Number: ACTRN12614001240639
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

healthy volunteers
- hemoglobin: males - 12.8 - 17.5 g/dl, females - 11.3 - 15.9 g/dl.
- B.W. > 55 kg, BMI - 18-30 kg/m2
- QTc < 450 msec
- females must not be pregnant and males and females must agree to use contraception during the study.
- able to give informed consent and comply with protocol.

Exclusion Criteria

- history or presence of severe gastrointestinal or systemic disorders (e.g. respiratory, endocrine, immunological, dermatological, neurological, psychiatric disease etc.)
- history or presence of renal insufficiency
- active liver disease/ liver transaminase greater than 1.5 X UNL
- history or presence of significant alcoholism or drug abuse within past 1 year
- history or presence of significant smoking/ consumption of tobacco/nicotine products and positive urine cotinine test at screening and check-in.
- difficulty in donating blood
- clinically significant laboratory findings during screening
- history or presence of clinically significant ECG abnormalities
- major illness/ surgery in last 3 months
- participated in drug research study within past 3 months
- donated 350 mL of blood in last 3 months
- used over-the-counter/ prescription/ herbal medications/ supplements within 30 days prior to receiving study drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified