Overview

Study of SM-88 in Advanced Cancers

Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Tyme, Inc
Criteria
Inclusion Criteria:

1. Healthy adult subjects, between 18 and 70 years of age, that are willing and able to
give written informed consent.

2. Subjects must be willing and able to comply with the clinical trial procedures and
timelines as outlined in the Time and Events Table.

3. Subjects should be continuous nonsmokers and have not used nicotine-containing
products for at least three months prior to dosing on Day 1.

4. Body mass index (BMI) between 20 and 29.

5. As outlined in section 5.1.1.1, subjects of childbearing potential must agree to use
an approved method of contraception for the duration of the clinical trial and for
three months after the dose of the IMP.

6. Must be able to swallow and retain oral medication.

7. Subjects must be willing to discontinue the use of any vitamins or herbal supplements
seven days prior to the IMP dosing and not resume the use of these supplements until
after PK sample is collected at 168h/Day 8.

Exclusion Criteria:

1. Prior medical history of any illness or injury that, in the opinion of the principal
investigator (PI), that may confound the results of the clinical trial or pose an
additional risk to the subject by his participation in the clinical trial.

2. Current or historic drug or alcohol abuse.

3. Unwillingness to discontinue alcohol intake for 24 hours prior to IMP dosing until the
collection of the PK sample at 168-h/Day 8.

4. Subjects should not have a history of lactose intolerance.

5. Concurrent use or known history of hypersensitivity to any of the components of SM 88.

6. Clinically significant abnormal laboratory test results at screening and/or baseline
visit as determined by PI.

7. Participation in another clinical trial within 30 days prior to screening.

8. Surgery within 90 days prior to dosing determined by the PI to be clinically relevant.

9. Subjects must be considered medically healthy with no clinically significant medical
history.

10. Subjects cannot be taking any concomitant medications. Subjects must be willing to
discontinue the use of any vitamins or herbal supplements seven days prior to the dose
date of the clinical trial and remain off these supplements until the last PK sample
is obtained (168h/Day 8).

11. Positive urine drug screening.

12. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HBsAg), or hepatitis C antibodies (HCV).