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Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male SubjectsPhase 1NCT02500953

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

A Phase 1 study testing ASP3325 in people with Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects, run by Astellas Pharma Inc at 1 site in Japan.

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

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. Read more about this study

Who is it for?
Ages 20 to 44 yearsHealthy volunteers can take part
What is being tested?
ASP3325
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
1 siteJapan
Study dates
Jul 2013to Dec 2013
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)
  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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:
Show all 36Show fewer
  • 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:
  • 1. 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):
  • 1. A positive result for HBs antigen, HBc antibody, HAV antibody (IgM), HCV antibody, HIV antigen/antibody, or syphilis.
  • Pregnancy test:
  • Female subjects who tested positive for pregnancy.
  • Failure to meet any criteria for 12-lead ECG for QT assessment at screening (Part 1 and Part 2 only).
  • Women who are or may be pregnant, lactating mothers, or women who wish to become pregnant during the study period.
  • Concurrent or history of drug allergies.
  • Upper gastrointestinal disease (e.g. nausea, vomiting, and stomachache) within 7 days before hospitalization (Day -2 [Part 1] or Day -3 [Part 2 and Part 3]).
  • Concurrent or previous hepatic disease (e.g. viral hepatitis and drug-induced liver injury).
  • Concurrent or previous heart disease (e.g. congestive heart failure, ischemic heart disease, and arrhythmia requiring treatment).
  • Concurrent respiratory disease (e.g. bronchial asthma and chronic bronchitis) or previous serious respiratory disease (except for a history of childhood asthma).
  • Concurrent gastrointestinal disease (e.g. peptic ulcer and gastroesophageal reflux esophagitis) or previous serious gastrointestinal disease (except for a history of appendicitis).
  • Previous operation of gut excision (except for a history of appendectomy).
  • Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, and interstitial nephritis; except for a history of calculus).
  • Concurrent or previous endocrine disease (e.g. hyperthyroid, hypothyroid, abnormality of growth hormone).
  • Concurrent or previous cerebrovascular disorder (e.g. cerebral infarction).
  • Concurrent or previous malignant tumor.
  • Excessive drinking or smoking habit. [Measure of "excessive"]:
  • Alcohol: ≥45 g/day [a large bottle of beer contains 25 g of alcohol, and 1 gou of Japanese sake contains 22 g of alcohol]
  • Smoking: ≥20 cigarettes/day
  • Irregular defecation pattern (less frequent than once a day) (Part 2 and Part 3 only).
  • Unable to consume or tolerate phosphorus- and calcium-controlled meals during hospitalization.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Study site

    Tokyo

Other trials in Japan

About this study

Official title: A Placebo-controlled, Double-blind, Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Japanese Male and Female Subjects and Caucasian Male Subjects

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.

Read the detailed description

<Part 1: Single ascending dose> Primary objective

  • To evaluate the safety and tolerability of a single oral dose of ASP3325 in non-elderly, healthy adult Japanese male and female, and Caucasian male subjects

Secondary objectives

  • To evaluate the pharmacokinetics and pharmacodynamics
  • To evaluate gender differences in the pharmacokinetics and pharmacodynamics
  • To evaluate ethnic differences in the pharmacokinetics and pharmacodynamics between Japanese and Caucasians

<Part 2: Multiple ascending dose> Primary objective

  • To evaluate the safety and tolerability of multiple oral doses of ASP3325 in non-elderly, healthy adult Japanese male and female subjects

Secondary objectives

  • To evaluate the pharmacokinetics and pharmacodynamics
  • To evaluate gender differences in the pharmacokinetics and pharmacodynamics

<Part 3: Evaluation of the effect of administration timing> Primary objective

  • To evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered three times a day at different administration timings of 30 minutes before a meal, during a meal, 30 minutes after a meal, and 2 hours after a meal in non-elderly, healthy adult Japanese male subjects in a crossover design

Secondary objective

  • To evaluate the safety and pharmacokinetics
Being tested
ASP3325, Placebo
Keywords
ASP3325, pharmacokinetics, pharmacodynamics

What participants receive

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

  • ASP3325Drug

  • PlaceboDrug

Study groups in NCT02500953
Study groupRoleWhat they receive
Japanese male single fasted ASP dose-1ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-2ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-3ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-4ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-5ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-6ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fasted ASP dose-7ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese female single fasted ASP dose-3ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese female single fasted ASP dose-5ExperimentalASP3325 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.
Receives: Drug: ASP3325
Caucasian male single fasted ASP dose-3ExperimentalASP3325 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.
Receives: Drug: ASP3325
Caucasian male single fasted ASP dose-5ExperimentalASP3325 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.
Receives: Drug: ASP3325
Japanese male single fed ASP dose-5ExperimentalASP3325 will be administered as a single oral dose with 240 mL of water to subjects after a meal.
Receives: Drug: ASP3325
Japanese male single fasted placeboExperimentalPlacebo 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.
Receives: Drug: Placebo
Japanese female single fasted placeboExperimentalPlacebo 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.
Receives: Drug: Placebo
Caucasian male single fasted placeboExperimentalPlacebo 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.
Receives: Drug: Placebo
Japanese male single fed placeboExperimentalPlacebo will be administered as a single oral dose with 240 mL of water to subjects after a meal.
Receives: Drug: Placebo
Japanese male multiple ASP dose-3ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese male multiple ASP dose-4ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese male multiple ASP dose-5ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese female multiple ASP dose-3ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese female multiple ASP dose-4ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese female multiple ASP dose-5ExperimentalASP3325 will be administered as multiple oral doses with 240 mL of water, three times a day, just after a meal.
Receives: Drug: ASP3325
Japanese male multiple PlaceboExperimentalPlacebo will be administered with 240 mL of water, three times a day, just after a meal.
Receives: Drug: Placebo
Japanese female multiple PlaceboExperimentalPlacebo will be administered with 240 mL of water, three times a day, just after a meal.
Receives: Drug: Placebo
Japanese male ASP dose-5 before a mealExperimentalASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
Receives: Drug: ASP3325
Japanese male ASP dose-5 during a mealExperimentalASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
Receives: Drug: ASP3325
Japanese male ASP dose-5 after a mealExperimentalASP3325 will be administered with 240 mL of water, three times a day, for 2 days.
Receives: Drug: ASP3325

What is being measured

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

  1. Safety developed by adverse events, Part 1

    Measured: Up to Day 7 under Fasted and Fed Conditions

  2. Safety developed by adverse events, Part 2

    Measured: Up to Day 13

  3. Safety developed by adverse events, Part 3

    Measured: Up to Day 8 in Period 4

  4. Safety developed by Vital signs, Part 1

    Measured: Up to Day 7

  5. Safety developed by Vital signs, Part 2

    Measured: Up to Day 13

  6. Safety developed by Vital signs, Part 3

    Measured: Up to Day 8 in Period 4

  7. Safety developed by Laboratory Tests, Part 1

    Measured: Up to Day 7 under Fasted and Fed Conditions

  8. Safety developed by Laboratory Tests, Part 2

    Measured: Up to Day 13

  9. Safety developed by Laboratory Tests, Part 3

    Measured: Up to Day 8 in Period 4

  10. Safety developed by 12-Lead ECG, Part 1

    ECG = electrocardiogram

    Measured: Up to Day 7 under Fasted and Fed Conditions

  11. Safety developed by 12-Lead ECG, Part 2

    ECG = electrocardiogram

    Measured: Up to Day 13

  12. Safety developed by 12-Lead ECG, Part 3

    ECG = electrocardiogram

    Measured: Up to Day 8 in Period 4

Secondary outcomes (15)

  1. 12-lead continuous ECG for QT assessment

    ECG: Electrocardiogram

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

  2. Standard 12-lead ECG for QT assessment

    ECG: Electrocardiogram

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

  3. Plasma concentration of ASP3325

    Measured: 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

  4. Urinary concentration of ASP3325

    Measured: 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

  5. Amount of phosphorus excreted in urine and FEP%

    FEP% = Fractional Phosphate Excretion

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

  6. Amount of phosphorus excreted in urine

    Measured: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2

  7. Amount of calcium excreted in urine

    Measured: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2

  8. Amount of phosphorus excreted in feces

    Measured: Day -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 in Part 2

  9. Amount of calcium excreted in feces

    Measured: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2

  10. Amount of FEP%

    FEP%：Fractional phosphate excretion

    Measured: Day -1, 1, 2, 7, 8, 9, and 10 in Part 2

  11. Amount of phosphorus excreted in urine

    Measured: Day -1, 1, 2, 3, and 4 in Part 3

  12. Amount of calcium excreted in urine

    Measured: Day -1, 1, 2, 3, and 4 in Part 3

  13. Amount of phosphorus excreted in feces

    Measured: Day -1, 1, 2, 3, and 4 in Part 3

  14. Amount of calcium excreted in feces

    Measured: Day -1, 1, 2, 3, and 4 in Part 3

  15. Amount of FEP%

    FEP%: Fractional phosphate excretion

    Measured: Day -1, 1, 2, 3, and 4 in Part 3

Timeline

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

  1. First posted17 Jul 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02500953
Sponsor's protocol ID
3325-CL-0001
Status last verified
Jul 2015
First submitted
15 Jul 2015
Last updated
17 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASP3325 in people with Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male 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 11 inclusion and 36 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 17 Jul 2015. 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. 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 developed by adverse events, Part 1 (time frame: Up to Day 7 under Fasted and Fed Conditions). The study lists 12 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 NCT02500953.

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 17 Jul 2015.

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