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

  • STATUS
    Recruiting
  • days left to enroll
    50
  • participants needed
    140
  • sponsor
    Sun Pharma Advanced Research Company Limited
Updated on 16 November 2021
Accepts healthy volunteers

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.

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

Details
Condition Healthy Volunteer Study
Treatment Matching Placebo, SCO-120
Clinical Study IdentifierNCT04242953
SponsorSun Pharma Advanced Research Company Limited
Last Modified on16 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Any major surgery, as determined by the Investigator, within 4 weeks of 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
Positive exclusion tests: human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus
Known and/ or suspected history of significant drug abuse as judged by the Investigator
Subjects will be excluded from the Study if they meet any of the following
criteria: (All Parts)
Blood transfusion within 4 weeks prior to IMP administration
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
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
History of alcohol abuse or excessive intake of alcohol, defined as regular weekly intake of more than 15 units of alcohol (Note: 1 unit equals 25 mL spirits, 125 mL wine, or 250 mL beer or lager) in the 12 months prior to study entry
Current or recent disease of the gastrointestinal tract that may impact drug absorption and may affect the PK of the IMP, or any gastrointestinal tract surgery history that may impact drug absorption
Continued use of caffeine or grapefruit juice or xanthine-containing drinks or food, e.g., coffee, tea, chocolate, red bull, or cola for 48 hours prior to dosing and till the last PK sample collection
Any concomitant clinically significant disorder, like infection, diabetes etc. that would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion which can have impact on study endpoints and/ safety of subjects as per PI discretion
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