Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants
20. januar 2022 oppdatert av: Cerevel Therapeutics, LLC
A Randomized, 3-Period Crossover Trial to Evaluate the Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Adult Participants
This is a Phase 1, single-center trial in healthy participants.
This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
Studieoversikt
Detaljert beskrivelse
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
-
Tempe, Arizona, Forente stater, 85283
- Celerion Inc.
-
-
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:
- Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
- Healthy as determined by medical evaluation by the investigator.
- Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs).
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
- Capable of giving signed informed consent and complying with study requirements.
Exclusion Criteria:
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
- Serious risk of suicide in the opinion of the investigator.
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
- Any condition that could possibly affect drug absorption.
Receipt of SARS-CoV2 vaccine or booster as follows:
- mRNA: within 14 days prior to dosing
- Non-mRNA: within 28 days prior to dosing
- Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
- Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
- Abnormal clinical laboratory test results or vital measurements at Screening.
- Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food)
Oral Dose
|
Tablets
|
|
Eksperimentell: Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food)
Oral Dose
|
Tablets
|
|
Eksperimentell: Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food)
Oral Dose
|
Tablets
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Single Dose: Peak Plasma Concentrations
Tidsramme: Day 1 to Day 4
|
Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
|
Single Dose: Area under the plasma concentration-time curve
Tidsramme: Day 1 to Day 4
|
Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
|
Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
Tidsramme: Day 1 to Day 4
|
Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
|
Single Dose: Time of Maximum Observed Plasma Concentrations
Tidsramme: Day 1 to Day 4
|
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions
|
Day 1 to Day 4
|
|
Secondary Objective: Single Dose: Peak Plasma Concentrations
Tidsramme: Day 1 to Day 4
|
Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions
|
Day 1 to Day 4
|
|
Secondary Objective: Single Dose: Area under the plasma concentration-time curve
Tidsramme: Day 1 to Day 4
|
Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions
|
Day 1 to Day 4
|
|
Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Tidsramme: Day 1 to Day 4
|
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions
|
Day 1 to Day 4
|
|
Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
Tidsramme: Day 1 to Day 4
|
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions
|
Day 1 to Day 4
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary Outcome (AE)
Tidsramme: Day 1 to Day 4
|
Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
|
Day 1 to Day 4
|
|
Secondary Outcome (ECGs)
Tidsramme: Day 1 to Day 4
|
Number of subjects with clinically significant changes in Electrocardiograms.
|
Day 1 to Day 4
|
|
Secondary Outcome (Labs)
Tidsramme: Day 1 to Day 4
|
Number of subjects with clinically significant changes in laboratory measures.
|
Day 1 to Day 4
|
|
Secondary Outcome (Vital Signs)
Tidsramme: Day 1 to Day 4
|
Number of subjects with clinically meaningful changes in vitals signs.
|
Day 1 to Day 4
|
|
Secondary Outcome (Physical/Neurological Exam)
Tidsramme: Day 1 to Day 4
|
Number of subjects with clinically significant changes in physical and neurological exams.
|
Day 1 to Day 4
|
|
Secondary Outcome (C-SSRS)
Tidsramme: Day 1 to Day 4
|
Changes from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS).
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide.
C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
|
Day 1 to Day 4
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Ann M Dandurand, MD, Cerevel Therapeutics, LLC
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)
2. november 2021
Primær fullføring (Faktiske)
21. november 2021
Studiet fullført (Faktiske)
7. desember 2021
Datoer for studieregistrering
Først innsendt
5. november 2021
Først innsendt som oppfylte QC-kriteriene
5. november 2021
Først lagt ut (Faktiske)
17. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CVL-865-1002
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
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