ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects

A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03361540

Enrollment

Registered

2017-12-05

Start date

2017-11-14

Completion date

2018-04-30

Last updated

2024-10-21

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

Conditions

Healthy Subjects

Keywords

Pharmacokinetics, Safety, ASP8302

Brief 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.

Interventions

DRUGASP8302

ASP8302 will be administered orally.

DRUGPlacebo

Placebo will be administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 44 Years

Healthy volunteers

Yes

Inclusion criteria

* 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 \[BMI = Body weight (kg) ÷ {Body height (m)2}\].

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety assessed by incidence of adverse events (AEs)	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	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	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	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	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	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	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.

Secondary

Measure	Time frame	Description
PK parameter for ASP8302: Accumulation Ratio for Cmax (Rac(Cmax)) in plasma	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
PK parameter for ASP8302: AUC from the Time of Dosing to the Last Measurable Concentration (AUClast) in plasma	Up to 72 hr after dosing in SAD part	To assess the PK of ASP8302 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	Up to 72 hr after dosing in SAD part Day 1 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Terminal Elimination Half-life (t1/2) in plasma	Up to 72 hr after dosing in SAD part Day 14 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Apparent Volume of Distribution during the Terminal Elimination Phase After Single Extra-Vascular Dosing (Vz/F) in plasma	Up to 72 hr after dosing in SAD part	To assess the PK of ASP8302 in SAD part.
PK parameter for ASP8302: Apparent Total Systemic Clearance After Single or Multiple Extra-Vascular Dosing (CL/F) in plasma	Up to 72 hr after dosing in SAD part Day 14 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) in plasma	Up to Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
Pharmacokinetics (PK) parameter for ASP8302: Maximum observed concentration (Cmax) in plasma	Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Fraction excreted into urine from the time of dosing to the 72 hours after dosing (Ae72%) in urine	Up to 72 hr after dosing in SAD part	To assess the PK of ASP8302 in SAD part.
PK parameter for ASP8302: Renal clearance (CLR) in urine	Up to 72 hr after dosing in SAD part Day 14 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Amount excreted into urine over the time interval between consecutive dosing (Aetau) in urine	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
PK parameter for ASP8302: Fraction excreted into urine over the time interval between consecutive dosing (Aetau%) in urine	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
Pharmacodynamic (PD) parameter for ASP8302: Pupil diameter	Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part	To assess the PD of ASP8302 in SAD part and MAD part.
PD parameter for ASP8302: Salivary secretion	Up to 24 hr after dosing in SAD part Up to Day 14 in MAD part	To assess the PD of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: Amount excreted into urine from the time of dosing to the 72 hours after dosing (Ae72) in urine	Up to 72 hr after dosing in SAD part	To assess the PK of ASP8302 in SAD part.
PK parameter for ASP8302: Time of the Maximum Concentration (tmax) in plasma	Up to 72 hr after dosing in SAD part Day 1 and Day 14 in MAD part	To assess the PK of ASP8302 in SAD part and 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	Up to 72 hr after dosing in SAD part Day 1 in MAD part	To assess the PK of ASP8302 in SAD part and MAD part.
PK parameter for ASP8302: AUC from the Time of Dosing Extrapolated to Time Infinity (AUCinf) in plasma	Up to 72 hr after dosing in SAD part	To assess the PK of ASP8302 in SAD part.
PK parameter for ASP8302: AUC from the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) in plasma	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
PK parameter for ASP8302: Peak-Trough Ratio (PTR) in plasma	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.
PK parameter for ASP8302: Accumulation Ratio for AUC (Rac(AUC)) in plasma	Day 14 in MAD part	To assess the PK of ASP8302 in MAD part.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026