Healthy Volunteer StudyPhase 1NCT04242953
Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subjects
A Phase 1 study testing SCO-120 in people with Healthy Volunteer Study, run by Sun Pharma Advanced Research Company Limited at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- SCO-120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Mar 2020to 21 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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) .
Who cannot join
- 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;
Show all 20Show fewer
- 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
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
BioPharma Services USA Inc.
Creve Coeur, Missouri, 63141
AXIS Clinicals
Dilworth, Minnesota, 56529-1342
About this study
Official title: A Multipart Phase 1 Study to Determine Safety, Tolerability and Pharmacokinetics of SCO-120 in Healthy Male and Post-menopausal Female Subjects
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.
Read the 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
- Conditions
- Healthy Volunteer Study
- Being tested
- SCO-120, matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCO-120Drug
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)
matching placeboDrug
Part A: single oral administration
Part C: multiple oral administration (14 day dosing)
| Study group | Role | What they receive |
|---|---|---|
| SCO-120 | Experimental | Not described Receives: Drug: SCO-120 |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Part A: safety and tolerability assessed
Measured: 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
Measured: Day 35
Secondary outcomes (1)
Part B: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Part B: safety and tolerability assessed
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start4 Mar 2020
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242953
- Sponsor's protocol ID
- SCO-120-19-18
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multipart Phase 1 Study to Determine Safety, Tolerability and Pharmacokinetics of SCO-120 in Healthy Male and Post-menopausal Female Subjects
- ClinicalTrials.gov ID
- NCT04242953
- Acronym / sponsor ID
- SCO-120-19-18
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2020 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCO-120 | Experimental | Drug: SCO-120 |
| Matching Placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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-
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCO-120Part 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) | Drug | SCO-120 |
| matching placeboPart A: single oral administration Part C: multiple oral administration (14 day dosing) | Drug | Matching Placebo |
Primary outcome
Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame: Day 14
Part A: safety and tolerability assessed
Part C: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame: Day 35
Part C: safety and tolerability assessed
1 secondary outcome
Part B: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0
Time frame: Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer Study
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Screening Protocol
Pain
RecruitingPhase 1
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Neoplasms, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCO-120 in people with Healthy Volunteer Study, run by Sun Pharma Advanced Research Company Limited at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0 (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.