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

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    140
  • sponsor
    Sun Pharma Advanced Research Company Limited
Updated on 16 May 2022
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 May 2022

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
Part B and C-
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
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

Inability to swallow oral medication
Inability to undergo venipuncture and/or tolerate venous access
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
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
Subjects with complaints of hot flashes at screening
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
History of abnormal vaginal bleeding within 3 months prior to screening and/ or
uterine malignancy
Positive exclusion tests: human immunodeficiency virus (HIV), hepatitis B surface
antigen, or hepatitis C virus
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
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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