A Clinical study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ZYKR1 in healthy volunteers.

Phase 1

• Registration Number: CTRI/2018/07/014927
• Lead Sponsor: Cadila Healthcare Ltd

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: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Healthy male or female between 18 and 55 years of age.

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

3.Body weight > 50 kg and BMI within the range 18.5-30 kg/m2 (Both inclusive).

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

5.QTc < 450 msec by Bazettes formula.

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

2.Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion-

a)cardiovascular, b)cerebrovascular,c)dermatological, d)gastrointestinal, e)gynecological f)hematological, g)hepatic, h)malignancy, i)metabolic, j)musculoskeletal, k)neurological, l)psychiatric, m)renal, n)respiratory,

o)venereal, p)any other major disorders

3.History or presence of smoking or consumption of tobacco/nicotine products and having a positive urine cotinine test before check-in.

4.Difficulty with donating blood.

5.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.

6.Pulse rate less than 60/minute and more than 100/minute.

7.Any clinically significant laboratory or ECG findings during screening.

8.Surgery within last 4 weeks or planned major surgery within next 3 months from the date of screening.

9.Volunteers who have participated in any drug research study within past 3 months.

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

11.Use of any over-the-counter (OTC), any prescription medications or alternative tradition of medicine (herbal medicines, homoeopathy, Siddha, Unani, etc.) within the 15 days or 5 half-lives (whichever is longer), prior to receiving study drug that might have impact on the clinical trial as per the investigator discretion.

12.History of allergic reaction to any opioid receptor agonist in the past.

13.Male subjects not willing to use contraceptives for a period of one month after receiving study drug.

14.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 1 month after the participation in this trial.

•Positive serum β-hcg level at the screening or check-in visit.

15.Subjects with SpO2 <95% (by pulse oximeter)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments.Timepoint: Time Frame: Upto 48 hours post dose

Secondary Outcome Measures

Name	Time	Method
1.Pharmacokinetic (PK) parameters, maximum observed plasma drug concentration, time to achieve maximum plasma concentration in <br/ ><br> a)Single Ascending Dose (SAD) study (Plan I) <br/ ><br> b)Single Dose in Female â?? Gender Effect Study (Plan II) <br/ ><br> <br/ ><br>Pharmacokinetics and safety parameters in female volunteers at preselected single dose will be compared with the results of similar single-dose study in male volunteers. <br/ ><br>2.Pharmacodynamic endpoint <br/ ><br>- Prolactin concentration. <br/ ><br> <br/ ><br>Timepoint: The venous blood samples will be collected for pharmacokinetic and pharmacodynamic assessment as per defined time points in protocol for upto 24 hours. Urine samples for PK analysis will be collected as per defined time periods in protocol for upto 48 hours.