A Phase 1, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of SM07883, a Novel DYRK1a Inhibitor, Following Oral Administration to Healthy Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease; Neurological - Alzheimer's disease

• Registration Number: ACTRN12619000327189
• Lead Sponsor: Samumed Pacific Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-04
• Study Completion: 2019-12-05
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Healthy adult females 18 to 70 years old; or, healthy adult males 18 to 70 years old, who are surgically sterile; or, healthy adult males greater than 55 years old with no interest in fathering a child in the future
2. Body mass index (BMI) of 19 to 30, inclusive
3. Subject must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed.
4. Willingness and ability to comply with all scheduled study visits, laboratory tests, contraception requirements, and other study procedures.
5. Willing to avoid extensive sun exposure, phototherapy, or use of a tanning salon for the duration of the study.

Exclusion Criteria

1. Women who are pregnant, lactating, or have a positive or indeterminate pregnancy result
2. Women of childbearing potential who are sexually active, and who are not willing to use an acceptable method of birth control during the study period
3. Men up to 55 years old (inclusive) who are of childbearing potential
4. Men greater than 55 years old of childbearing potential who may wish to father a child in the future
5. Men greater than 55 years old of childbearing potential who are sexually active and have a partner who is capable of becoming pregnant, neither of whom are agreeable to using an acceptable method of birth control
6. History of or current allergy to investigational product ingredients.
7. Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, musculoskeletal, immunologic, neurologic, or dermatologic disease
8. History of malignancy within the last 5 years
9. Recent treatment with an investigational product.
10. History of long QT syndrome and/or clinically significant ECG
11. History of clinically significant increased intracranial pressure, bleeding diathesis, cardiopulmonary instability, or soft tissue infection at the proposed puncture site
12. Clinically significant laboratory abnormalities at Screening
13. Recent active infection or febrile illness
14. Recent serious illness requiring hospitalization
15. Any chronic condition that has not been well controlled. 16. Uncontrolled hypertension
17. Regular alcohol abuse
18. A history of abuse of prescription or illicit drugs
19. Positive urine drug screen
20. Recent use of strong inhibitors or inducers of CYP3A4 and CYP2D6 enzymes (eg grapefruit, grapefruit juice, and star fruit).
21. Subjects who have a current or pending disability claim, workers’ compensation, or litigation(s)
22. Subjects who are immediate family members of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site.
23. Subjects employed by Samumed Pacific Pty Ltd, or any of its affiliates or development partners responsible for the conduct of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified