A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects

NCT02500953 | Completed Phase 1

• 1 other identifier: 3325-CL-0001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to evaluate the safety and tolerability of a single and multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day.

Conditions

Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects

Keywords

ASP3325; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (12)

• Safety developed by adverse events, Part 1

  Up to Day 7 under Fasted and Fed Conditions

• Safety developed by adverse events, Part 2

  Up to Day 13

• Safety developed by adverse events, Part 3

  Up to Day 8 in Period 4

• Safety developed by Vital signs, Part 1

  Up to Day 7

• Safety developed by Vital signs, Part 2

  Up to Day 13

• Safety developed by Vital signs, Part 3

  Up to Day 8 in Period 4

• Safety developed by Laboratory Tests, Part 1

  Up to Day 7 under Fasted and Fed Conditions

• Safety developed by Laboratory Tests, Part 2

  Up to Day 13

• Safety developed by Laboratory Tests, Part 3

  Up to Day 8 in Period 4

• Safety developed by 12-Lead ECG, Part 1

  ECG = electrocardiogram

  Up to Day 7 under Fasted and Fed Conditions

• Safety developed by 12-Lead ECG, Part 2

  ECG = electrocardiogram

  Up to Day 13

• Safety developed by 12-Lead ECG, Part 3

  ECG = electrocardiogram

  Up to Day 8 in Period 4

Secondary Outcomes (15)

• 12-lead continuous ECG for QT assessment

  Up to Day 2 in examination only for administration under fasted condition in Part 1 and Part 2

• Standard 12-lead ECG for QT assessment

  Day -1 ~ 2 in Part 1 and from Day -1 ~1 and Day7~8 in Part 2

• Plasma concentration of ASP3325

  Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day 1, 2, 4, 6, 7, 8, 9 and 10 in Part 2, Day 1, 2, 3, 4, 5 in Part 3

• Urinary concentration of ASP3325

  Day 1, 2, 3 and 4 in Part 1 under Fasted and Fed Conditions, Day -1, 1, 2, 7, and 8 in Part 2, Day -1, 1, 2, 3, 4, 5 in Part 3

• Amount of phosphorus excreted in urine and FEP%

  Day 1, 2, 3 and 4 in Part 1 under Fasted Conditions

Study Arms (27)

Japanese male single fasted ASP dose-1

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-2

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-3

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-4

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-6

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fasted ASP dose-7

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese female single fasted ASP dose-3

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese female single fasted ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Caucasian male single fasted ASP dose-3

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Caucasian male single fasted ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: ASP3325

Japanese male single fed ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as a single oral dose with 240 mL of water to subjects after a meal.

Drug: ASP3325

Japanese male single fasted placebo

EXPERIMENTAL

Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: Placebo

Japanese female single fasted placebo

EXPERIMENTAL

Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: Placebo

Caucasian male single fasted placebo

EXPERIMENTAL

Placebo will be administered as a single oral dose with 240 mL of water to subjects who have been fasting from 22:00 on the day before administration.

Drug: Placebo

Japanese male single fed placebo

EXPERIMENTAL

Placebo will be administered as a single oral dose with 240 mL of water to subjects after a meal.

Drug: Placebo

Japanese male multiple ASP dose-3

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese male multiple ASP dose-4

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese male multiple ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese female multiple ASP dose-3

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese female multiple ASP dose-4

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese female multiple ASP dose-5

EXPERIMENTAL

ASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.

Drug: ASP3325

Japanese male multiple Placebo

EXPERIMENTAL

Placebo will be administered with 240 mL of water, three times a day, just after a meal.

Drug: Placebo

Japanese female multiple Placebo

EXPERIMENTAL

Placebo will be administered with 240 mL of water, three times a day, just after a meal.

Drug: Placebo

Japanese male ASP dose-5 before a meal

EXPERIMENTAL

ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.

Drug: ASP3325

Japanese male ASP dose-5 during a meal

EXPERIMENTAL

ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.

Drug: ASP3325

Japanese male ASP dose-5 after a meal

EXPERIMENTAL

ASP3325 will be administered with 240 mL of water, three times a day, for 2 days.

Drug: ASP3325

Interventions

ASP3325 DRUG

Caucasian male single fasted ASP dose-3; Caucasian male single fasted ASP dose-5; Japanese female multiple ASP dose-3; Japanese female multiple ASP dose-4; Japanese female multiple ASP dose-5; Japanese female single fasted ASP dose-3; Japanese female single fasted ASP dose-5; Japanese male ASP dose-5 after a meal; Japanese male ASP dose-5 before a meal; Japanese male ASP dose-5 during a meal; Japanese male multiple ASP dose-3; Japanese male multiple ASP dose-4; Japanese male multiple ASP dose-5; Japanese male single fasted ASP dose-1; Japanese male single fasted ASP dose-2; Japanese male single fasted ASP dose-3; Japanese male single fasted ASP dose-4; Japanese male single fasted ASP dose-5; Japanese male single fasted ASP dose-6; Japanese male single fasted ASP dose-7; Japanese male single fed ASP dose-5

Placebo DRUG

Caucasian male single fasted placebo; Japanese female multiple Placebo; Japanese female single fasted placebo; Japanese male multiple Placebo; Japanese male single fasted placebo; Japanese male single fed placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body weight (at screening)
• Japanese male: ≥50.0 kg, \<80.0 kg
• Japanese female: ≥40.0 kg, \<70.0 kg
• Caucasian male: ≥50.0 kg, \<100.0 kg
• BMI (at screening)
• Japanese: ≥17.6 kg/m2, \<26.4 kg/m2
• Caucasians: ≥18.5 kg/m2, \<30.0 kg/m2
• Ethnicity
• Japanese: (1) The investigator or subinvestigator will confirm the ethnicity based on appearance (skin color: yellow) and the fact that both parents and four grandparents are of the same race (lineage) based on an interview. (2) The subject has not resided outside Japan for 5 years or longer.
• Caucasians: (1) The investigator or subinvestigator will confirm ethnicity based on appearance (skin color: white or brown) and the fact that both parents and four grandparents are of the same race (lineage) based on an interview. (2) The subject has not resided outside the subject's own country for 5 years or longer.
• Healthy, as judged by the investigator or subinvestigator based on the results of a medical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospitalization to immediately before administration.

You may not qualify if:

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening or during the period from the screening to hospitalization (Day -2 \[Part 1\] or Day -3 \[Part 2 and Part 3\]) or is scheduled to receive any investigational drugs.
• Donated more than or equal to 400 mL of whole blood within 90 days before the screening or during the period from the screening to hospitalization (Day -2 \[Part 1\] or Day -3 \[Part 2 and Part 3\]), more than or equal to 200 mL of whole blood within 30 days, or blood components within 14 days before the screening, or is scheduled to donate more than or equal to 400 mL of whole blood or blood components.
• Received medications, vitamins including vitamin D, or supplements including calcium, iron, magnesium, or niacin (nicotinic acid or nicotinamide), or is scheduled to receive medications, within 7 days before hospitalization (Day -2 \[Part 1\] or Day -3 \[Part 2 and Part 3\]).
• A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead electrocardiogram (ECG) at screening or Day -1.
• Any deviation of the following criteria for laboratory tests at screening or Day -1. The normal ranges specified at the study site or the test/assay organization will be used as the normal ranges in this clinical study.
• Hematology:
• A deviation of +20% from the upper limit or -20% lower limit of the normal range. However, if the WBC is within the normal range, each differential count of leukocytes will be ignored.
• Biochemistry:
• A deviation from the normal range for AST, ALT, Cre, blood glucose, and serum electrolytes (Na, K, Cl, Mg, Ca, and P).
• A deviation of +20% from the upper limit or -20% lower limit of the normal range for other parameters than the above. However, the lower limit of the normal range will not be established for parameters for which a deviation from the lower limit is not considered clinically significant (AST, ALT, γ-GTP, T-Bil, D-Bil, I-Bil, ALP, LDH, CK, T-Cho, TG, TBA, BUN, Cre, and UA). TBA and iPTH will only be confirmed by laboratory tests at screening.
• Urinalysis:
• A deviation from the normal range of each test parameter (female subjects in Part 2 who are menstruating at screening may be eligible even if urinary blood is positive).
• Urinary drug abuse test:
• \. A positive result for benzodiazepines, cocaine-based narcotics, analeptic drugs, cannabis, barbituric acid derivatives, morphine-based narcotics, phencyclidines, or tricyclic antidepressants.
• Immunological test (at screening only):

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Interventions

ASP3325

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

JP (1)