- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04976270
A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects
11. februar 2022 opdateret af: Galapagos NV
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG3667 in Adult, Healthy Male Subjects
This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
23
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Gent, Belgien, 9000
- Drug Research Unit Ghent
-
-
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 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
This list only contains the key inclusion criteria.
Exclusion Criteria:
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that has resolved at least 3 months prior to first dosing of the IP.
This list only contains the key exclusion criteria.
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: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: GLPG3667 SD
Participants will receive a single dose of GLPG3667
|
GLPG3667 kapsler
|
Placebo komparator: Placebo SD
Participants will receive a single dose of matching placebo
|
Matchende placebo kapsler
|
Eksperimentel: GLPG3667 MD
Participants will receive repeated doses of GLPG3667 for 13 days.
|
GLPG3667 kapsler
|
Placebo komparator: Placebo MD
Participants will receive repeated doses of matching placebo for 13 days.
|
Matchende placebo kapsler
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Tidsramme: From screening through study completion, an average of 3 months
|
To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
|
From screening through study completion, an average of 3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Maximum observed plasma concentration (Cmax) of GLPG3667 - SD
Tidsramme: Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Maximum observed plasma concentration (Cmax) of GLPG3667 - MD
Tidsramme: Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD
Tidsramme: Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD
Tidsramme: Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
Terminal elimination half-life (t1/2) of GLPG3667 - SD
Tidsramme: Between Day 1 pre-dose and Day 4
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 4
|
Terminal elimination half-life (t1/2) of GLPG3667 - MD
Tidsramme: Between Day 1 pre-dose and Day 16
|
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
|
Between Day 1 pre-dose and Day 16
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Natalia Rueda-Rincon, MD, PhD, Galapagos NV
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. juli 2021
Primær færdiggørelse (Faktiske)
14. januar 2022
Studieafslutning (Faktiske)
14. januar 2022
Datoer for studieregistrering
Først indsendt
19. juli 2021
Først indsendt, der opfyldte QC-kriterier
19. juli 2021
Først opslået (Faktiske)
26. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GLPG3667-CL-118
- 2021-002488-23 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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