None listed
Conditions
Brief summary
This is a first in man trial with ZYAN1. The primary aim of this study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics, pharmacodynamics, gender and food effect of ZYAN1 in healthy volunteers.
Interventions
The interventional product, ZYAN1, will be administered as an oral tablet.
The first part of the study (Plan I) is an single ascending dose (SAD) cohort (panel) design in which different patient panels will receive ZYAN1 1001 as a single dose. The starting dose in first panel will be 10 mg. Subsequent doses will be 25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg for panel 2, 3, 4, 5, 6 and 7. The subsequent panels will be conducted in new healthy males provided the previous panel is well tolera
The interventional product, ZYAN1, will be administered as an oral tablet. The first part of the study (Plan I) is an single ascending dose (SAD) cohort (panel) design in which different patient panels will receive ZYAN1 1001 as a single dose. The starting dose in first panel will be 10 mg. Subsequent doses will be 25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg for panel 2, 3, 4, 5, 6 and 7. The subsequent panels will be conducted in new healthy males provided the previous panel is well tolerated. The second part of the study (Plan II) is a multiple ascending dose (MAD) cohort (panel) design in which different patient panels will receive the same single dose of ZYAN1 1001 on Day 1, Day 3 and Day 5. The starting dose in first panel will be x1 mg where "x" stands for starting dose which will be decided based on the results of the SAD study. Subsequent doses will be x2 mg, x3 mg and x4 mg for panel 2, 3 and 4. The subsequent panels will be conducted in new healthy males provided the previous panel is well tolerated. In the third part of the study (Plan III), ZYAN1 1001 will be administered once in fed and fasted conditions to healthy males and healthy females. The dose for this part will be decided based on the results of the first part of the study. The IP will be administered to the volunteer at site under the supervision of a trained study personnel. IP accountability will be documented in a log and verified by an unblinded monitor.
Sponsors
Cadila Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Outcome results
None listed