ASP8302 Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single dose of ASP8302 dose-1 Subjects will receive a single dose of ASP8302. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Experimental: Single dose of ASP8302 dose-2 Subjects will receive a single dose of ASP8302. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Experimental: Single dose of ASP8302 dose-3 Subjects will receive a single dose of ASP8302. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Experimental: Single dose of ASP8302 dose-4 Subjects will receive a single dose of ASP8302. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Placebo Comparator: Single dose of Placebo Subjects will receive a single dose of Placebo. |
Drug: Placebo
Placebo will be administered orally.
|
| Experimental: Multiple dose of ASP8302 dose-5 Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Experimental: Multiple dose of ASP8302 dose-6 Subjects will receive once daily dosing of ASP8302 for 14 consecutive days at the same dose level. |
Drug: ASP8302
ASP8302 will be administered orally.
|
| Placebo Comparator: Multiple dose of Placebo Subjects will receive once daily dosing of Placebo for 14 consecutive days. |
Drug: Placebo
Placebo will be administered orally.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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: 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.
- 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.
- 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: 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site JP00001 | Toshima | Tokyo | Japan |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Director: Medical Director, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8302-CL-0101