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

NCT04242953 | Completed Phase 1 FDA Drug

• 1 other identifier: SCO-120-19-18
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 3

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.

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (2)

• Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0

  Part A: safety and tolerability assessed

  Day 14

• Part C: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0

  Part C: safety and tolerability assessed

  Day 35

Secondary Outcomes (1)

• Part B: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0

  Day 42

Study Arms (2)

SCO-120

EXPERIMENTAL

Drug: SCO-120

Matching Placebo

PLACEBO COMPARATOR

Drug: matching placebo

Interventions

SCO-120 DRUG

Part A: single oral administration Part B: single oral administration in Period 1 and Period 2 (crossover design) Part C: multiple oral administration (14 day dosing)

SCO-120

matching placebo DRUG

Part A: single oral administration Part C: multiple oral administration (14 day dosing)

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Part A- Healthy postmenopausal female volunteers Part B \& Part C- Healthy Male or postmenopausal female volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal female volunteers will be included in the study if they meet all of the following criteria:
• Part A-
• 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.
• All parts-
• 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
• Females who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level of ≥ 40 mIU/mL at screening
• Non-smokers or abstain from any tobacco usage, including smokeless tobacco, nicotine patches, etc. for entire study duration including screening period; subjects must have urine cotinine levels below those measured for smokers (\< 200 ng/mL) .

You may not qualify if:

• 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
• History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients);
• Received another investigational agent within 30 days (or for investigational agents with long half life a washout of 5 half-lives will be required) prior to IMP administration or intake of an investigational drug during the course of this study;
• Intake of any prescribed medication/drugs within at least 14 days and/or over-the-counter drugs within at least 7 days (or less than 5 half-lives of the respective drug) prior to administration of the IMP;
• Known and/ or suspected history of significant drug abuse as judged by the Investigator;
• Positive screen for drugs of abuse at Screening visit or positive screen for alcohol or drugs of abuse on admission to the study centre prior to the first IMP administration;

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (3)

AXIS Clinicals

Dilworth, Minnesota, 56529-1342, United States

Location

BioPharma Services USA Inc.

Creve Coeur, Missouri, 63141, United States

Location

BioPharma Services Inc.

Toronto, Ontario, ON M9L 3A2, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 27, 2020
• Study Start: March 4, 2020
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)