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Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Postmenopausal Female Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242953
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: SCO-120 Drug: matching placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 1 Randomized, Double Blind, Placebo Controlled Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120, in Healthy Postmenopausal Females
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Experimental: Arm A Drug: SCO-120
single oral administration

Placebo Comparator: Arm B Drug: matching placebo
single oral administration




Primary Outcome Measures :
  1. number of subjects with treatment emergent adverse events [ Time Frame: Day 8 after single dose administration in each cohort ]
    safety and tolerability profile of SCO-120


Secondary Outcome Measures :
  1. Maximum observed plasma concentration [ Time Frame: Day 8 after single dose administration in each cohort ]
    Plasma Pharmacokinetic parameters of SCO-120

  2. time to maximum observed plasma concentration [ Time Frame: Day 8 after single dose administration in each cohort ]
    Plasma Pharmacokinetic parameters of SCO-120

  3. terminal rate constant [ Time Frame: Day 8 after single dose administration in each cohort ]
    Plasma Pharmacokinetic parameters of SCO-120

  4. terminal half-life [ Time Frame: Day 8 after single dose administration in each cohort ]
    Plasma Pharmacokinetic parameters of SCO-120



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy postmenopausal female volunteers
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions, and be accessible for follow-up visits
  3. Assessed as healthy based on no clinically significant abnormality identified on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory screening tests
  4. Age > 18 years
  5. Weight over 50 kg and with a body mass index of 18.0 to 33.0 kg/m2 (inclusive)
  6. Female who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level of ≥ 40 mIU/mL at screening.

Exclusion Criteria:

  1. Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
  2. Inability to swallow oral medication
  3. Inability to undergo venipuncture and/or tolerate venous access
  4. Female on Hormone Replacement Therapy, or having been on the same in the past 6 months
  5. History of abnormal vaginal bleeding and/ or uterine malignancy
  6. Positive exclusion tests: human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C virus
  7. Known and/ or suspected history of significant drug abuse as judged by the Investigator.
  8. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242953


Contacts
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Contact: Sun Pharma Advanced Research Company Limited +1 (609) 720-5333 clinical.trials@sparcmail.com

Locations
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Colombia
SPARC Site 1 Recruiting
Montana, United States, Colombia, 65201
Contact: Dr Kathleen Doisy         
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT04242953    
Other Study ID Numbers: SCO-120-19-18
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No