A Multipart Phase 1 Study to Determine Safety, Tolerability and Pharmacokinetics of SCO-120 in Healthy Male and Post-menopausal Female Subjects

Sun Pharma Advanced Research Company Limited3 sites in 2 countries140 target enrollmentMarch 4, 2020

ConditionsHealthy Volunteer Study

InterventionsSCO-120 matching placebo

DrugsSCO-120 matching placebo

Overview

Phase: Phase 1
Intervention: SCO-120
Conditions: Healthy Volunteer Study
Sponsor: Sun Pharma Advanced Research Company Limited
Enrollment: 140
Locations: 3
Primary Endpoint: Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Multipart Phase 1 Randomized, Double blind and Placebo controlled Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in healthy male and postmenopausal female volunteers.

Detailed Description

Part A- approximately 76 (Approximately 8 sequential cohorts of 8 subjects per cohort) Part B- Up to approximately, 32 healthy males or post-menopausal female subjects will be enrolled Part C- Approximately 32 healthy male or postmenopausal female subjects (4 sequential cohorts of 8 subjects) will be enrolled

Registry

clinicaltrials.gov

Start Date

March 4, 2020

End Date

October 21, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Pharma Advanced Research Company Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy postmenopausal female volunteers will be included in the study if they meet all of the following criteria:
•Healthy postmenopausal female subjects, aged \> 18 years, Weight over 50 kg and with a body mass index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part.
•Did not donate 50-349 mL blood within 30 days or ≥350 mL blood within 3 months prior to IMP administration and agrees not to make blood donations, including red blood cells, plasma, platelets, or whole blood for the entire study duration.
•Part B and C-
•Healthy male and postmenopausal female subjects, aged ≥ 18 years, with a body mass index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part.
•Did not donate 50-499 mL blood within 30 days or ≥500 mL blood within 56 days prior to IMP administration and agrees not to make blood donations, including red blood cells, plasma, platelets, or whole blood for the entire study duration
•Men who are able to father children must agree to use medically acceptable methods of contraception and NOT donate sperm during the study and for 90 days after the end of the study. Medically acceptable methods of contraception include using a condom with a female partner of child-bearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicide. Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
•Willing and able to give written, signed and dated informed consent (or by subject's legally acceptable representative/impartial witness when applicable) and is available for the entire study
•Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (as per section 4.5), and be accessible for follow-up visits
•Assessed as healthy based on no clinically significant abnormality identified on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory screening tests

Exclusion Criteria

•Subjects will be excluded from the Study if they meet any of the following criteria: (All Parts)
•Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration;
•Blood transfusion within 4 weeks prior to IMP administration;
•Inability to swallow oral medication;
•Inability to undergo venipuncture and/or tolerate venous access;
•Female on Hormone Replacement Therapy, or having been on the same in the past 6 months;
•Active liver disease or history of liver disease (such as hepatitis) in the past 6 months which can have impact on study endpoints and/ safety of subjects as per investigator discretion;
•Medical history of thromboembolic disorders or with risks (such as hematologic or rheumatologic disorders); recent history of thrombophlebitis;
•Subjects with complaints of hot flashes at screening;
•History of abnormal vaginal bleeding within 3 months prior to screening and/ or uterine malignancy