A single-dose, two-way crossover study to assess the absorption of two oral formulations of STC-15 and evaluate the effect of food on the pharmacokinetics of a single dose of STC-15 tablet in healthy participants

An open-label, single oral dose, randomized, two-way crossover study to assess the relative bioavailability of two oral formulations of STC-15 and evaluate the effect of food on the pharmacokinetics of a single dose of STC-15 tablet in healthy participants

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56605614

Enrollment

Registered

2025-10-31

Start date

2025-12-09

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This is a healthy volunteer study Other

Interventions

This is a study in healthy participants to compare the relative bioavailability of a 50 mg STC-15 tablet and a 30 mg STC-15 capsule (Part 1) and to assess the effect of food on the PK of a 50 mg STC-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Body mass index of 18 to 32 kg/m2 2. In good general health 3. Can swallow and retain oral medications

Exclusion criteria

Exclusion criteria: 1. A history or presence of clinically significant allergies 2. Clinically significant heart disease, renal disease, or neurological disorder 3. History or presence of significant serious skin disease 4. Major abdominal surgery and/or significant bowel resection 5. Known psychiatric or substance abuse disorder 6. Poor venous access that would limit blood draws 7. Unacceptable organ function 8. Clinically significant abnormal ecg or blood pressure 9. Positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies 10. Received any vaccine within 14 days 11. Current smoker or has used more than 5 cigarettes or equivalent amount of other nicotine-containing products per week 12. Participants under 18 will not be involved 13. Aboriginal or Torres Strait Islander participants will not be targeted.

Design outcomes

Primary

Measure	Time frame
PK parameters: AUC0-t, AUC0-inf, Cmax, Tmax, Kel, t1/2, CL/F, Vd/F. The dose normalized PK parameters (AUC0-t/D, AUC0-inf/D, and Cmax/D) will also be calculated using non compartmental analysis (NCA) at all PK timepoints from dosing through 120 hours for each period.	—

Secondary

Measure	Time frame
Safety and tolerability: AEs, clinical laboratory test results (hematology, serum chemistry, and urinalysis), vital sign measurements, 12-lead ECG results, and physical examination findings measured using patient records at screening (Day-28) through End of Treatment (Day 16).	—

Countries

Australia

Contacts

Public ContactChristopher Argent

christopher.argent@scientiaclinicalresearch.com.au+61 02 9382 5844

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026