Pharmacokinetic AnalysisPhase 1NCT07445464

An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers

A Phase 1 study testing Flunarizine in people with Pharmacokinetic Analysis, run by Aspartes Pharmaceuticals, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetic Analysis
What is being tested?: Flunarizine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteAustralia
Study dates: 9 Apr 2026to 27 Aug 2026
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
Female participants of non-childbearing potential must be:

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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.
Sexually active female participants of childbearing potential and non-sterile male participants must be willing to use an acceptable contraceptive method throughout the study as detailed in section 7.1.
Willing to take off dentures or mouth piercing at the time of dosing.
Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

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.

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Positive pregnancy test or lactating female participant.
Positive urine drug screen, urine cotinine test, or alcohol breath test.
Known allergic reactions to flunarizine or other related drugs, or to any excipient in the formulation.
Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 40 or over 90 mmHg, or heart rate less than 40 or over 100 bpm) at screening. Any abnormalities or deviations outside the normal range for vital signs and ECG can be repeated at the discretion of the investigator and/or designee.
History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month, or use of cocaine, phencyclidine [PCP], crack, opioid derivatives (including heroin) or amphetamine derivatives within 3 months prior to screening.
History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 14 standard drinks for females or 21 standard drinks for males of alcohol per week (1 standard drink = 375 mL of mid-strength beer 3.5% alcohol/volume, 100 mL of wine 13.5% alcohol/volume, or 30 mL of distilled alcohol 40% alcohol/volume).
Use of medications within the the following timeframes prior to dosing:
Depot injections or drug implants: within 3 months.
Strong CYP2D6 inhibitors or strong CYP inducers such as fluoxetine, paroxetine, bupropion, quinidine, cinacalcet, terbinafine, mirabegron, darifenacin, rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's wort: within 30 days.
Prescription medications: within 14 days.
Vaccines (including COVID 19 vaccines): within 14 days.
Over the counter (OTC) medications and natural health products (herbal, homeopathic, probiotics, vitamins, minerals, amino acids, essential fatty acids, protein supplements): within 7 days, except occasional paracetamol up to 2 g/day.
No concomitant medications are permitted during the study except those required for AE management or those specifically exempted by the Investigator and/or designee as unlikely to affect PK or safety.
Concomitant participation in an interventional or observational trial, or administration of an investigational device or non-biological drug within 30 days (or 5 half-lives, whichever is longer) prior to dosing, or administration of an investigational biological drug within 90 days (or 5 half-lives, whichever is longer) prior to dosing.
Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
Hemoglobin <125 g/L for males and <110 g/L for females. One repeat test is permitted at the discretion of the Investigator and/or designee.
Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that in the opinion of the investigator and/or designee would be likely to interfere with successful completion of the dosing procedure.
Any reason which, in the opinion of the Investigator and/or designee, would prevent the participant from participating in the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Linear Early Phase Limited
Nedlands, Western Australia, 6009

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of Asp-001, 2 Mg And 5 Mg Orally Disintegrating Tablets (Formulations A And B) With Sibelium® 5 Mg Tablet in Healthy Participants

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.

Conditions: Pharmacokinetic Analysis
Being tested: Flunarizine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FlunarizineDrug
ODT formulation for buccal administration
FlunarizineDrug
Also called Sibelium
oral tablet

Study groups in NCT07445464
Study group	Role	What they receive
Treatment A: ASP-001 Formulation A, 5 mg	Experimental	Not described Receives: Drug: Flunarizine
Treatment B: ASP-001 Formulation A, 2 mg	Experimental	Not described Receives: Drug: Flunarizine
Treatment C: ASP-001 Formulation B, 5 mg	Experimental	Not described Receives: Drug: Flunarizine
Treatment D: ASP-001 Formulation B, 2 mg	Experimental	Not described Receives: Drug: Flunarizine
Treatment E: Sibelium, 5 mg	Active comparator	identical active ingredient Receives: Drug: Flunarizine

What is being measured

The primary outcome is the main question the study is designed to answer.

Frel
relative bioavailability calculated on the ratio of intervention to control
Measured: Through Study Day 5 for each intervention and control
AUC(0-inf)
area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Through Study Day 5 for each intervention and control
AUC(0-t)
area under the concentration-time curve from time zero until the last observed concentration
Measured: Through Study Day 5 for each intervention and control
Cmax
maximal observed concentration
Measured: Through Study Day 5 for each intervention and control
Tmax
time when the maximal concentration is observed
Measured: Through Study Day 5 for each intervention and control
T½ el
terminal elimination half-life
Measured: Through Study Day 5 for each intervention and control
Kel
terminal elimination rate constant
Measured: Through Study Day 5 for each intervention and control
Cl/F
Apparent clearance
Measured: Through Study Day 5 for each intervention and control
Vz/F
apparent volume of distribution
Measured: Through Study Day 5 for each intervention and control

Secondary outcomes (3)

Evaluate the safety and tolerability
Measure the incidence and severity of treatment-emergent adverse events
Measured: Throughout the study period
Metabolic Profile
Measure the plasma concentration of liver metabolites M1 (N1 dealkylation), M2 (phenyl oxidation) and M3 (N4 dealkylation)
Measured: Through Study Day 5 for each intervention and control
Dose Proportionality
Measure plasma flunarizine concentrations of 2 mg and 5 mg for each ASP-001 ODT formulation and model for dose response
Measured: Through Study Day 5 for each intervention and control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202627 Aug 2026

First posted3 Mar 2026
Study start9 Apr 2026
Primary completion23 Jul 2026
Study completion27 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pharmacokinetic AnalysisStudies 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: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: 5-way, randomized, open-label, sequential single administration under fasting conditions
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07445464
Sponsor's protocol ID: ASP-001-01
Status last verified: Oct 2026
First submitted: 21 Feb 2026
Last updated: 6 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Open-Label, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of Asp-001, 2 Mg And 5 Mg Orally Disintegrating Tablets (Formulations A And B) With Sibelium® 5 Mg Tablet in Healthy Participants
ClinicalTrials.gov ID: NCT07445464
Acronym / sponsor ID: ASP-001-01
Conditions: Pharmacokinetic Analysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Aspartes Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 9 Apr 2026 (actual)
Primary completion: 23 Jul 2026 (actual)
Study completion: 27 Aug 2026 (actual)
First posted: 3 Mar 2026 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5
Model description: 5-way, randomized, open-label, sequential single administration under fasting conditions

Arm	Type	Receives
Treatment A: ASP-001 Formulation A, 5 mg	Experimental	Drug: Flunarizine
Treatment B: ASP-001 Formulation A, 2 mg	Experimental	Drug: Flunarizine
Treatment C: ASP-001 Formulation B, 5 mg	Experimental	Drug: Flunarizine
Treatment D: ASP-001 Formulation B, 2 mg	Experimental	Drug: Flunarizine
Treatment E: Sibelium, 5 mg	Active comparator	Drug: Flunarizineidentical active ingredient

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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.
Female participants of non-childbearing potential must be:
Sexually active female participants of childbearing potential and non-sterile male participants must be willing to use an acceptable contraceptive method throughout the study as detailed in section 7.1.

Key exclusion criteria (24 listed)

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.

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
FlunarizineODT formulation for buccal administration	Drug	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
FlunarizineAlso: Sibeliumoral tablet	Drug	Treatment E: Sibelium, 5 mg

Primary outcome

Frel
Time frame: Through Study Day 5 for each intervention and control
relative bioavailability calculated on the ratio of intervention to control
AUC(0-inf)
Time frame: Through Study Day 5 for each intervention and control
area under the concentration-time curve from time zero to infinity (extrapolated)
AUC(0-t)
Time frame: Through Study Day 5 for each intervention and control
area under the concentration-time curve from time zero until the last observed concentration
Cmax
Time frame: Through Study Day 5 for each intervention and control
maximal observed concentration
Tmax
Time frame: Through Study Day 5 for each intervention and control
time when the maximal concentration is observed
T½ el
Time frame: Through Study Day 5 for each intervention and control
terminal elimination half-life
Kel
Time frame: Through Study Day 5 for each intervention and control
terminal elimination rate constant
Cl/F
Time frame: Through Study Day 5 for each intervention and control
Apparent clearance
Vz/F
Time frame: Through Study Day 5 for each intervention and control
apparent volume of distribution

3 secondary outcomes

Evaluate the safety and tolerability
Time frame: Throughout the study period
Metabolic Profile
Time frame: Through Study Day 5 for each intervention and control
Dose Proportionality
Time frame: Through Study Day 5 for each intervention and control

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 6 Oct 2026.
Individual participant dataSharing planned: No

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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.

Peter Schrader, MBBS, FRACP principal investigator

Linear Clinical Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flunarizine in people with Pharmacokinetic Analysis, run by Aspartes Pharmaceuticals, Inc. at 1 site in Australia.

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 11 inclusion and 24 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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. 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?

Frel (time frame: Through Study Day 5 for each intervention and control). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07445464.

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 6 Oct 2026.