- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04935320
Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution
1. november 2021 opdateret af: Heptares Therapeutics Limited
Phase 1, Randomised, Open-label, 3-period Crossover, Single Dose Study in Healthy Subjects, to Assess Relative Bioavailability From an Oral Capsule of HTL0016878 Citrate Salt Versus an Oral Solution of HTL0016878 Hydrochloride Salt
This is a randomised, open-label, 3-period, crossover single dose study to assess the relative bioavailability of two formulations of HTL0016878: an oral solution of HCl salt form (the reference product) and an oral capsule containing citrate salt (the test product); and of the effect of food on the pharmacokinetics of the capsule formulation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Fifteen healthy male or female subjects will be enrolled.
Each subject will have 3 study sessions and receive a single oral dose of 10 mg HTL0016878 on Day 1 of each study session.
Subjects will receive the HTL0016878.HCl oral solution in the fasted state in 1 session, and the HTL0016878.citrate
capsule, in the fasted state and after a high-fat meal, respectively, in the other 2 sessions.
Each subject will be randomised to 1 of 3 treatment sequences (5 subjects to each sequence).
There will be a washout of at least 10 days between doses.
Subjects will be screened within 35 days before their first dose of HTL0016878.
In each study session, subjects will be resident on the ward from the day before dosing (Day -1) until completion of procedures 72 h after their dose (Day 4).
Subjects will return for a follow up visit 10-13 days after their final dose of trial medication.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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London, Det Forenede Kongerige, NW10 7EW
- Hammersmith Medicines Research Ltd (HMR)
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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
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy male or females, aged 18-50 years
- Female subjects must agree to use highly effective contraception
- Weigh 60 kg or more, with a BMI in the range 18.0-30.0 kg/m2
- Sufficient intelligence to understand the nature of the trial
- Willingness to give written consent to participate
- Agree to use the contraception requirements of the trial
- Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System
Exclusion Criteria:
- Woman who is pregnant or lactating
- Clinically relevant abnormal history, physical findings, ECG, or laboratory values
- Presence or history of acute or chronic illness, or mental health problem
- Impaired neurological, endocrine, thyroid, cardiovascular, respiratory, gastrointestinal, hepatic or renal function, diabetes mellitus, coronary heart disease, or history of any psychiatric disorder or psychotic mental illness
- Cancer during the 5 years before screening
- Supine blood pressure and heart rate outside the ranges: 90-140 mm Hg systolic and 50-90 mm Hg diastolic blood pressure; heart rate 45-80 beats/min
- Supine QT interval (QTcF) outside the ranges 300-450 msec (men) and 300-470 msec (women)
- Personal or family history of long QT syndrome or family sudden death
- Positive test for hepatitis B, hepatitis C or HIV
- Aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase or total bilirubin levels > 1.5 times the upper limit of normal
- Creatinine clearance < 80 mL/min/1.73 m2
- Presence or history of drug or alcohol abuse in the past 5 years; or regular intake of more than 21 units of alcohol weekly (for men) or 14 units of alcohol weekly (for women); or use of cigarettes, tobacco and/or nicotine-containing products during the 3 months before dosing
- Evidence of drug abuse or positive alcohol or cotinine test results
- Positive pregnancy test
- Habitual and heavy consumption of caffeinated beverages
- Use of a prescription or over-the-counter medicine, any herbal remedy, or nutritional supplement
- Receipt of a vaccine against COVID-19 in the 14 days before dosing
- Received live attenuated vaccination within 6 weeks prior to Screening
- History of severe allergies
- Use of any drugs that are inhibitors of CYP2D6
- Poor metaboliser of CYP2D6
- History of epilepsy or seizures
- Any disease associated with cognitive impairment and/or psychosis
- Suicidal thoughts or ideation, or insomnia
- Any history of mental illness (including anxiety, depression), which required medical intervention
- Presence or history of severe adverse reaction to any drug
- Surgery or medical condition that might affect absorption of medicines
- Receipt of an investigational product as part of another clinical trial within the 3 months before dosing in this study
- Receipt of HTL0016878 in a previous clinical trial
- Loss of more than 400 mL blood during the 3 months before dosing
- Unwilling to eat a high-fat breakfast
- Possibility that the volunteer will not cooperate with the requirements of the protocol
- Objection by GP to volunteer entering trial
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Oral Solution Fasted
HTL0016878.HCl 10 mg, single dose, oral solution, fasted
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Oral solution fasted
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Eksperimentel: Oral Capsule Fasted
HTL0016878.citrate 10 mg, single dose, oral capsule, fasted
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Oral capsule fed or fasted
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Eksperimentel: Oral Capsule Fed
HTL0016878.citrate 10 mg, single dose, oral capsule, fed
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Oral capsule fed or fasted
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Concentration of HTL0016878 in plasma Cmax
Tidsramme: 0-72 hours
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Pharmacokinetics
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0-72 hours
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Concentration of HTL0016878 in plasma AUC
Tidsramme: 0-72 hours
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Pharmacokinetics
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0-72 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment Emergent Adverse Events
Tidsramme: Baseline up to 13 days post-dose
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Safety and Tolerability
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Baseline up to 13 days post-dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
27. juli 2021
Primær færdiggørelse (Faktiske)
29. oktober 2021
Studieafslutning (Faktiske)
29. oktober 2021
Datoer for studieregistrering
Først indsendt
21. juni 2021
Først indsendt, der opfyldte QC-kriterier
21. juni 2021
Først opslået (Faktiske)
23. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. november 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. november 2021
Sidst verificeret
1. november 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HTL0016878-102
- 18-018 (Hammersmith Medicines Research Ltd)
- 2018-003685-14 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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 .
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