Healthy SubjectsPhase 1NCT03361540
ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
A Phase 1 study testing ASP8302 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects. Read more about this study
- Who is it for?
- Ages 20 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ASP8302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteJapan
- Study dates
- 14 Nov 2017to 30 Apr 2018
- 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 20 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
- Body-mass index (BMI) at screening: ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].
Who cannot join
- Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
- Subjects who conducted or is scheduled to conduct any of the blood donation or blood drawing in designated period before Day -2
- Subject who received or is scheduled to receive any medications within seven days before the hospital admission.
- Any deviation from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or on the day of hospital admission (Day -1).
- Subject who meets any of the criteria for laboratory tests at screening or on the day of hospital admission (Day -2).
- Any deviation from the normal range of routine 12-lead electrocardiogram at screening.
Show all 19Show fewer
- Subjects with a complication or history of drug allergies.
- Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission.
- Subjects with a complication or history of hepatic disease.
- Subjects with a complication or history of cardiac disease.
- Subjects with a complication or history of respiratory disease except for history of asthma in childhood.
- Subjects with a complication or history of gastrointestinal disease except for a history of appendicitis.
- Subjects with a history of gastrointestinal resection except for appendicitis.
- Subjects with a complication or history of renal disease except for a history of calculus.
- Subjects with a complication or history of endocrine disease.
- Subjects with a complication or history of cerebrovascular disease.
- Subjects with a complication or history of malignant tumor.
- Subjects who received ASP8302 previously.
- Subjects who have a habit of excessive smoking or drinking alcohol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.
- Conditions
- Healthy Subjects
- Being tested
- ASP8302, Placebo
- Keywords
- Pharmacokinetics, Safety, ASP8302
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8302Drug
ASP8302 will be administered orally.
PlaceboDrug
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Single dose of ASP8302 dose-1 | Experimental | Subjects will receive a single dose of ASP8302. Receives: Drug: ASP8302 |
| Single dose of ASP8302 dose-2 | Experimental | Subjects will receive a single dose of ASP8302. Receives: Drug: ASP8302 |
| Single dose of ASP8302 dose-3 | Experimental | Subjects will receive a single dose of ASP8302. Receives: Drug: ASP8302 |
| Single dose of ASP8302 dose-4 | Experimental | Subjects will receive a single dose of ASP8302. Receives: Drug: ASP8302 |
| Single dose of Placebo | Placebo comparator | Subjects will receive a single dose of Placebo. Receives: Drug: Placebo |
| Multiple dose of ASP8302 dose-5 | Experimental | Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. Receives: Drug: ASP8302 |
| Multiple dose of ASP8302 dose-6 | Experimental | Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. Receives: Drug: ASP8302 |
| Multiple dose of Placebo | Placebo comparator | Subjects will receive once daily dosing of Placebo for 14 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by incidence of adverse events (AEs)
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Measured: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part
Safety assessed by vital signs: Body temperature
To assess vital signs as a criteria of safety variables.
Measured: Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part
Safety assessed by vital signs: Blood pressure
To assess vital signs as a criteria of safety variables.
Measured: Up to Day 6 in SAD part Up to Day 19 in MAD part
Safety assessed by vital signs: Pulse rate
To assess vital signs as a criteria of safety variables.
Measured: Up to Day 6 in SAD part Up to Day 19 in MAD part
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to Day 6 in SAD part Up to Day 19 in MAD part
Safety assessed by cardiac troponin
To assess the cardiovascular system function as a criteria of safety variables.
Measured: Up to Day 6 in SAD part Up to Day 19 in MAD part
Safety assessed by standard 12-lead electrocardiogram
To assess the cardiovascular system function as a criteria of safety variables.
Measured: Up to Day 6 in SAD part Up to Day 19 in MAD part
Secondary outcomes (21)
Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 1 in MAD part
PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma
To assess the PK of ASP8302 in SAD part.
Measured: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma
To assess the PK of ASP8302 in SAD part.
Measured: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 1 in MAD part
PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma
To assess the PK of ASP8302 in SAD part.
Measured: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma
To assess the PK of ASP8302 in MAD part.
Measured: Up to Day 14 in MAD part
PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine
To assess the PK of ASP8302 in SAD part.
Measured: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine
To assess the PK of ASP8302 in SAD part.
Measured: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Renal clearance (CLR) in urine
To assess the PK of ASP8302 in SAD part and MAD part.
Measured: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine
To assess the PK of ASP8302 in MAD part.
Measured: Day 14 in MAD part
Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter
To assess the PD of ASP8302 in SAD part and MAD part.
Measured: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
PD parameter for ASP8302: Salivary secretion
To assess the PD of ASP8302 in SAD part and MAD part.
Measured: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start14 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361540
- Sponsor's protocol ID
- 8302-CL-0101
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2017
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03361540
- Acronym / sponsor ID
- 8302-CL-0101
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics, Safety, ASP8302
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Dec 2017 (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.
The objective of this study is to evaluate the safety, tolerability and pharmacokinetic of single/multiple ascending oral doses of ASP8302 in non-elderly healthy Japanese male and female subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single dose of ASP8302 dose-1 | Experimental | Drug: ASP8302Subjects will receive a single dose of ASP8302. |
| Single dose of ASP8302 dose-2 | Experimental | Drug: ASP8302Subjects will receive a single dose of ASP8302. |
| Single dose of ASP8302 dose-3 | Experimental | Drug: ASP8302Subjects will receive a single dose of ASP8302. |
| Single dose of ASP8302 dose-4 | Experimental | Drug: ASP8302Subjects will receive a single dose of ASP8302. |
| Single dose of Placebo | Placebo comparator | Drug: PlaceboSubjects will receive a single dose of Placebo. |
| Multiple dose of ASP8302 dose-5 | Experimental | Drug: ASP8302Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
| Multiple dose of ASP8302 dose-6 | Experimental | Drug: ASP8302Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
| Multiple dose of Placebo | Placebo comparator | Drug: PlaceboSubjects will receive once daily dosing of Placebo for 14 consecutive days. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight at screening: ≥ 50.0 kg and < 80.0 kg for male, ≥ 40.0 kg and < 70.0 kg for female.
- Body-mass index (BMI) at screening: ≥ 17.6 kg/m2 and < 26.4 kg/m2 [BMI = Body weight (kg) ÷ {Body height (m)2}].
Key exclusion criteria (19 listed)
- Subjects who participated or are scheduled to participate in any clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -2).
- Subjects who conducted or is scheduled to conduct any of the blood donation or blood drawing in designated period before Day -2
- Subject who received or is scheduled to receive any medications within seven days before the hospital admission.
- Any deviation from any of the normal range of blood pressure, pulse rate, body temperature and standard 12-lead electrocardiogram at screening or on the day of hospital admission (Day -1).
- Subject who meets any of the criteria for laboratory tests at screening or on the day of hospital admission (Day -2).
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 |
|---|---|---|
| ASP8302ASP8302 will be administered orally. | Drug | Multiple dose of ASP8302 dose-5, Multiple dose of ASP8302 dose-6, Single dose of ASP8302 dose-1, Single dose of ASP8302 dose-2, Single dose of ASP8302 dose-3, Single dose of ASP8302 dose-4 |
| PlaceboPlacebo will be administered orally. | Drug | Multiple dose of Placebo, Single dose of Placebo |
Primary outcome
Safety assessed by incidence of adverse events (AEs)
Time frame: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Safety assessed by vital signs: Body temperature
Time frame: Up to Day 6 in SAD part Up to Day 19 in multiple ascending dose (MAD) part
To assess vital signs as a criteria of safety variables.
Safety assessed by vital signs: Blood pressure
Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part
To assess vital signs as a criteria of safety variables.
Safety assessed by vital signs: Pulse rate
Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part
To assess vital signs as a criteria of safety variables.
Number of participants with laboratory value abnormalities and/or AEs
Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part
Number of participants with potentially clinically significant laboratory values.
Safety assessed by cardiac troponin
Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part
To assess the cardiovascular system function as a criteria of safety variables.
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Day 6 in SAD part Up to Day 19 in MAD part
To assess the cardiovascular system function as a criteria of safety variables.
21 secondary outcomes
Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part
PK parameter for ASP8302: Area under the concentration-time curve (AUC) from the time of dosing to 24h after dosing (AUC24) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 1 in MAD part
PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma
Time frame: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma
Time frame: Day 14 in MAD part
PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma
Time frame: Day 14 in MAD part
PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma
Time frame: Day 14 in MAD part
PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma
Time frame: Day 14 in MAD part
PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma
Time frame: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Time Point Prior to the Time Point Corresponding to the First Measurable (Non-zero) Concentration (tlag) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 1 in MAD part
PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma
Time frame: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma
Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma
Time frame: Up to Day 14 in MAD part
PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine
Time frame: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine
Time frame: Up to 72 hr after dosing in SAD part
PK parameter for ASP8302: Renal clearance (CLR) in urine
Time frame: Up to 72 hr after dosing in SAD part Day 14 in MAD part
PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine
Time frame: Day 14 in MAD part
PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine
Time frame: Day 14 in MAD part
Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter
Time frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
PD parameter for ASP8302: Salivary secretion
Time frame: Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part
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 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
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 ASP8302 in people with Healthy Subjects, run by Astellas Pharma Inc at 1 site in Japan.
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 2 inclusion and 19 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 21 Oct 2024. 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Safety assessed by incidence of adverse events (AEs) (time frame: Up to Day 6 in single ascending dose (SAD) part Up to Day 19 in MAD part). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.