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Study to Evaluate the Safety and Tolerability of ASP8062 in Healthy Japanese Male and Female Subjects

30. september 2018 opdateret af: Astellas Pharma Inc

ASP8062 Phase 1 Study - A Placebo-controlled, Single and Multiple Ascending Oral Dose Study in Non-elderly Healthy Japanese Male and Female Subjects -

The purpose of this study is to evaluate the safety and tolerability and evaluate pharmacokinetics of single and multiple ascending oral doses of ASP8062 in nonelderly Japanese male and female subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Tokyo
      • Sumida, Tokyo, Japan
        • Site JP00001

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 44 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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/m^2 and < 26.4 kg/m^2 [BMI = Body weight (kg) ÷ {Body height (m)^2}].
  • Female subjects must agree to consistently use 2 forms of highly effective birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
  • Female subjects must not donate ova starting at informed consent and throughout the clinical study period, and for 28 days after the final study drug administration.
  • Male subjects and female spouse/partners who are of childbearing potential must be using condom and one of the highly effective birth control starting informed consent throughout the clinical study period and for 90 days after final study drug, if vasectomy is not performed for male subjects.
  • Male subjects must not donate sperm starting at informed consent and throughout the clinical study period, and for 90 days after study drug administration.

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 received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission.
  • Any deviation from the normal range of blood pressure, pulse, body temperature, or routine 12-lead ECG at screening or on the day of hospital admission (Day -1).
  • Subjects who meet any of the criterion for laboratory tests at screening or on the day of hospital admission (Day -2).
  • Any deviation from the normal range of routine 12-lead ECG at screening.
  • Subjects with a complication or history of drug allergies.
  • Subjects who developed upper gastrointestinal symptoms (nausea, vomiting, stomachache, etc.) within seven days before the hospital admission.
  • Subjects with a history of gastrointestinal resection except for appendicitis.
  • Subjects with a complication or history of hepatic disease, cardiac disease, respiratory disease, gastrointestinal disease, renal disease, endocrine disease, cerebrovascular disease or malignant tumor.
  • Subjects who received ASP8062 previously.
  • Subject has a relevant history of suicide attempt or suicidal behavior.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ASP8062 lower dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
Eksperimentel: ASP8062 middle dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
Eksperimentel: ASP8062 higher dose
Subjects will receive a single dose of ASP8062 on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
ASP8062 will be administered orally.
Placebo komparator: Placebo
Subjects will receive a single dose of Placebo on Day 1, followed by 5 days of washout (Days 2-6) and once daily dosing for 14 consecutive days (Days 7-20) at the same dose level.
Placebo vil blive indgivet oralt.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety assessed by incidence of adverse events
Tidsramme: Up to Day 38
Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA).
Up to Day 38
Safety assessed by vital signs: supine blood pressure
Tidsramme: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by vital signs: supine pulse rate
Tidsramme: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by vital signs: axillary body temperature
Tidsramme: Up to Day 38
To assess the vital sign as a criteria of safety and tolerability variables.
Up to Day 38
Orthostatic challenge tests
Tidsramme: Up to Day 20
To assess the orthostatic challenge tests as a criteria of safety and tolerability variables.
Up to Day 20
Safety assessed by laboratory tests: Hematology
Tidsramme: Up to Day 38
To assess hematology as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Biochemistry
Tidsramme: Up to Day 38
To assess biochemistry as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by laboratory tests: Urinalysis
Tidsramme: Up to Day 38
To assess urinalysis as a criteria of safety and tolerability variables.
Up to Day 38
Safety assessed by 12-lead electrocardiogram
Tidsramme: Up to Day 21
To assess the cardiovascular system functioning as a criteria of safety and tolerability variables.
Up to Day 21
Columbia-Suicide Severity Rating Scale
Tidsramme: Up to Day 20
To assess the suicide risk
Up to Day 20
Safety assessed by body weight
Tidsramme: Up to Day 38
To assess the body weight as a criteria of safety and tolerability variables.
Up to Day 38

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics (PK) parameter for ASP8062: Maximum observed concentration (Cmax)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time to maximum concentration (Tmax)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Terminal elimination half-life (t1/2)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Apparent total systemic clearance after single or multiple extra-vascular dosing (CL/F)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Area under the concentration-time curve (AUC) from the time of dosing to 24 h after dosing (AUC24)
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing extrapolated to time infinity (AUCinf)
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the last measurable concentration (AUClast)
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Time point prior to the time point corresponding to the first measurable (non-zero) concentration (tlag)
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: Apparent volume of distribution during the terminal elimination phase after single extra-vascular dosing (Vz/F)
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part.
Up to Day 6
PK parameter for ASP8062: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Tidsramme: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
PK parameter for ASP8062: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Tidsramme: From Day 7 to Day 20
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 20
PK parameter for ASP8062: Percentage of AUCinf that is estimated by extrapolation (AUCinf (%extrap))
Tidsramme: Up to Day 6
To assess the PK of ASP8062 in single dose part
Up to Day 6
PK parameter for ASP8062: Terminal elimination rate constant (Lambda z)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
PK parameter for ASP8062: Time of the last measurable concentration (tlast)
Tidsramme: Up to Day 38
To assess the PK of ASP8062 in single dose part and multiple dose part.
Up to Day 38
Accumulation Ratio (Rac) of Cmax
Tidsramme: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Rac of AUC
Tidsramme: From Day 7 to Day 38
To assess the PK of ASP8062 in multiple dose part.
From Day 7 to Day 38
Peak-Trough Ratio for last dosing in multiple dose part
Tidsramme: Day 20 and Day 21
To assess the PK of ASP8062 in multiple dose part.
Day 20 and Day 21

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. juni 2017

Primær færdiggørelse (Faktiske)

6. oktober 2017

Studieafslutning (Faktiske)

6. oktober 2017

Datoer for studieregistrering

Først indsendt

9. juni 2017

Først indsendt, der opfyldte QC-kriterier

9. juni 2017

Først opslået (Faktiske)

12. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ASP8062

3
Abonner