An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers (NCT07445464) | Clinical Trial Compass
Not Yet RecruitingPhase 1
An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers
12 participantsStarted 2026-04-09
Plain-language summary
This study will assess the pharmacokinetics (PKs), safety and tolerability of ASP-001 in healthy volunteers. ASP-001 is an orally disintegrating tablet (ODT) formulation of flunarizine. This study will assess two formulations, Formulation A and Formulation B, at dose levels of 2 and 5 mg compared to the reference product, the Sibelium brand of flunarizine 5 mg tablet.
Whilst this is not a first-in-human (FIH) study of flunarizine, which is available in countries outside of Australia and has been studied extensively, it is a FIH study of ASP-001. In this open-label study, 12 participants will be assigned to one of five dosing sequences, in which they will receive a single dose of ASP-001 or Sibelium 5 mg in five separate dosing periods. The study drugs will be:
* Treatment A: ASP-001 Formulation A, 5 mg
* Treatment B: ASP-001 Formulation A, 2 mg
* Treatment C: ASP-001 Formulation B, 5 mg
* Treatment D: ASP-001 Formulation B, 2 mg
* Treatment E: Sibelium, 5 mg Each dosing period will be separated by at least a 7-day washout period after the day of dosing. Approximately 14 days after the fifth and final dosing day, participants will return to the site to complete their end of study assessments.
Aboriginal and Torres Strait Islander participants will not be targeted directly; however, they will be permitted to be on-study if they meet all of the eligibility criteria. Participants under the age of 18 will not be permitted on study.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, ≥18 and ≤65 years of age at screening, with body mass index (BMI) ≥18.5 and ≤32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
. Healthy as defined by:
. the absence of clinically significant illness and surgery (including abdominal or gastrointestinal surgery that may alter drug absorption) within 4 weeks prior to dosing.
. the absence of clinically significant history of neurological (including Parkinson's disease or other extrapyramidal disorders), endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric (including depression), gastrointestinal, renal, hepatic, and metabolic disease.
. Non smoker, defined as no use of tobacco or nicotine containing products (including cigarettes, e cigarettes, cigars, pipes, or smokeless tobacco) for at least 6 months prior to screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frel
Timeframe: Through Study Day 5 for each intervention and control
2
AUC(0-inf)
Timeframe: Through Study Day 5 for each intervention and control
3
AUC(0-t)
Timeframe: Through Study Day 5 for each intervention and control
4
Cmax
Timeframe: Through Study Day 5 for each intervention and control
5
Tmax
Timeframe: Through Study Day 5 for each intervention and control
6
T½ el
Timeframe: Through Study Day 5 for each intervention and control
7
Kel
Timeframe: Through Study Day 5 for each intervention and control
. Female participants of non-childbearing potential must be:
. post-menopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle stimulating hormone (FSH) levels ≥40 mIU/mL; or
. surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy) or having had a tubal ligation performed at least 3 months prior to dosing.
Exclusion criteria
. Any clinically significant abnormal finding at physical examination at screening.
. PHQ-9 score \> 10 at screening or baseline (Day -1).
. Clinically significant abnormal laboratory test results or positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody at screening. Any abnormalities or deviations outside the normal ranges for any clinical laboratory testing can be repeated once at the discretion of the investigator and/or designee.
. Any of the following laboratory parameters above 1.5× upper limit of normal (ULN) at screening or baseline (Day -1): AST, ALT, direct bilirubin, indirect bilirubin, and total bilirubin. Values over 1.5× ULN may be repeated once for confirmation if the investigator considers it reasonable (e.g., potential elevation due to recent strenuous physical activity).
. History of clinically significant liver disease, impaired synthetic liver function, or jaundice. Resolved childhood jaundice is not exclusionary.
. Value of creatinine clearance (CrCl) \<60 mL/min, as estimated by the Cockcroft-Gault equation.
. Positive pregnancy test or lactating female participant.
. Positive urine drug screen, urine cotinine test, or alcohol breath test.
Timeframe: Through Study Day 5 for each intervention and control
9
Vz/F
Timeframe: Through Study Day 5 for each intervention and control