- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04464239
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
5. februar 2021 oppdatert av: Taisho Pharmaceutical R&D Inc.
A Randomized, Double-blind, Placebo-controlled, Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 Administered Orally to Healthy Male and Female Participants
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers.
This Phase I study is composed of two parts; Part A (Single Ascending Dose) and Part B (Repeated Dose).
The study employs a randomized, double-blind, placebo-controlled, parallel group design to evaluate the single and repeat-dose safety and pharmacokinetics of TS-142 in healthy participants.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
28
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
-
Austin, Texas, Forente stater, 78744
- PPD Phase I Unit
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adult male and female participants between 18 and 55 years of age, inclusive
- Body weight ≥ 45 kg at screening and admission visits.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening visit.
Exclusion Criteria:
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and/or admission visits.
- Clinically significant abnormal physical examination (including neurological assessments), vital signs, or 12-lead ECGs at the screening and/or admission visits.
- QTcF >450 msec for male participants or QTcF >470 msec for female participants at the screening and/or admission visits.
- Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, neurological, immunologic, ophthalmologic, metabolic or oncological disease.
- History or present diagnosis of sleep disorders.
- Currently experiencing sleep disturbance related to postmenopausal symptoms at the screening and/or admission visits.
- History or presence of suicidal behavior, defined as participants who have answered 'YES' to any of the C-SSRS suicidal behavior questions at the screening and/or admission visits.
- Positive urine screen for alcohol or controlled substances at the screening or admission visits.
- Recent history (within the previous 6 months) of alcohol or drug abuse.
- Regular alcohol consumption of > 2 units/day or 10 units/week during the last 3 months prior to screening. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, a glass (125 mL) of wine, or 25 mL of spirits.
- Current use, or use of tobacco or tobacco-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) during the month prior to screening, or positive urine cotinine screen (>400 ng/mL) at the screening and/or admission visits.
- History of and/or current evidence of serologic positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies 1 and 2.
- Donation of one or more units of blood, plasma (including platelet donations), or acute loss of an equivalent amount of blood within 60 days prior to screening visit (one unit= 450 mL).
- Exposure to any investigational product within 60 days prior to screening.
- Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to administration of the study drug.
- Participants who regularly consume >500 mg of caffeine on a daily basis.
- Is known to be allergic to the study drug or any components of the study drug.
- Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or is unwilling to avoid strenuous exercise at any time throughout the study.
- Participants who work night shifts or need to work night shifts during the trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Part A: Cohort 1: TS-142 10 mg
Single dose of TS-142 10 mg or placebo in a fasted condition
|
TS-142 tablets
TS-142 matching placebo tablets
|
Eksperimentell: Part A: Cohort 2: TS-142 30 mg
Single dose of TS-142 30 mg or placebo in a fasted condition.
|
TS-142 tablets
TS-142 matching placebo tablets
|
Eksperimentell: Part B: Cohort 4: TS-142 20 mg
Daily doses of 20 mg TS-142 or placebo for 7 days before bedtime.
|
TS-142 tablets
TS-142 matching placebo tablets
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence and severity of Adverse Events
Tidsramme: Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
|
Part A: Day 1 to Day 10; Part B: Day 1 to Day 16
|
|
TS-142 Plasma Pharmacokinetic Profile - Cmax
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Maximum plasma concentration
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - Tmax
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Time to maximum plasma concentration
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-∞)
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Area Under the Concentration vs.
Time Curve from Time Zero to Infinity
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-last)
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Area Under the Concentration vs.
Time Curve from Time Zero to Last Measurable Concentration
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - AUC(0-tau)
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Area Under the Concentration vs.
Time Curve over a Dosing Interval
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - %AUCex
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Percentage of the area extrapolated for calculation of AUC(0-∞)
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - λz
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Elimination rate constant
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - t1/2
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Apparent terminal half-life
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - CL/F
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Apparent oral clearance
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Plasma Pharmacokinetic Profile - Vd,z/F
Tidsramme: Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
Volumes of distribution
|
Part A: Day 1 predose and at multiple time points (up to 48 hours) postdose; Part B: Day 1 predose and at multiple time points (up to 12 hours) postdose, Day 2 to Day 6 predose, Day 7 predose and at multiple time points (up to 48 hours) postdose
|
TS-142 Urine Pharmacokinetic Profile - Ae
Tidsramme: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Amount excreted in urine
|
Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
TS-142 Urine Pharmacokinetic Profile - Fe%
Tidsramme: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Percent of dose excreted in urine
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Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
TS-142 Urine Pharmacokinetic Profile - CLr
Tidsramme: Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Renal clearance
|
Part A: Day 1 predose and pooled for multiple intervals (up to 48 hours) postdose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Taisho Director, Taisho Pharmaceutical R&D Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. september 2020
Primær fullføring (Faktiske)
21. januar 2021
Studiet fullført (Faktiske)
21. januar 2021
Datoer for studieregistrering
Først innsendt
6. juli 2020
Først innsendt som oppfylte QC-kriteriene
6. juli 2020
Først lagt ut (Faktiske)
9. juli 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- TS142-US101
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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