RDEA3170 Tablet and Capsule Bioavailability Study
17. november 2017 opdateret af: Ardea Biosciences, Inc.
A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
35
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
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Austin, Texas, Forenede Stater, 78744
-
-
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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Subject is able to understand the study procedures and the risks involved, and is willing to provide written informed consent before the first study-related activity.
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject has a Screening serum urate level of 4 to 7 mg/dL.
- Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion Criteria:
- Subject has a history or suspicion of kidney stones.
- Subject has undergone major surgery within 3 months prior to Screening.
- Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.
- Subject has clinically unacceptable physical examination, per the Investigator's judgment.
- Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.
- Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.
- Subject has a serum creatinine value above the upper limit of normal at the Screening visit.
- Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.
- Subject has a history of cardiac abnormalities
- Subject cannot swallow multiple tablets or capsules.
- Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
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: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment A
RDEA3170, 5 mg (FN24), administered in the fasted state.
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
|
|
Eksperimentel: Treatment B
RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
|
|
Eksperimentel: Treatment C
RDEA3170, 10 mg (FN25), administered in the fasted state.
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
|
|
Eksperimentel: Treatment D
RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
|
|
Eksperimentel: Treatment E
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Andre navne:
|
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Eksperimentel: Treatment I
RDEA3170, 10 mg (FN26), administered in the fasted state.
|
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Andre navne:
|
|
Eksperimentel: Treatment J
RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
|
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Andre navne:
|
|
Eksperimentel: Treatment K
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
|
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Andre navne:
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Tidsramme: Day 1, 5, 9, 13, 17
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Cmax is the maximum observed concentration of a drug after administration
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Day 1, 5, 9, 13, 17
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Time of Occurrence of Maximum Observed Concentration (Tmax)
Tidsramme: Day 1, 5, 9, 13, 17
|
Tmax is the time of occurrence of cmax
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Day 1, 5, 9, 13, 17
|
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Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
Tidsramme: Day 1, 5, 9, 13, 17
|
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
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Day 1, 5, 9, 13, 17
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Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
Tidsramme: Day 1, 5, 9, 13, 17
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AUC 0-∞ is a meausre of total concentration from time zero to infinity
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Day 1, 5, 9, 13, 17
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Apparent Terminal Half-life (t1/2)
Tidsramme: Day 1, 5, 9, 13, 17
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t1/2 is a measure of apparent terminal half-life
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Day 1, 5, 9, 13, 17
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Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
Tidsramme: Day 1, 5, 9, 13, 17
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Cmax is the maximum observed concentration of a drug after administration
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Day 1, 5, 9, 13, 17
|
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AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
Tidsramme: Day 1, 5, 9, 13, 17
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AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
|
Day 1, 5, 9, 13, 17
|
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AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
Tidsramme: Day 1, 5, 9, 13, 17
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AUC 0-∞ is a meausre of total concentration from time zero to infinity
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Day 1, 5, 9, 13, 17
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacodynamics (PD) Profile of RDEA3170
Tidsramme: Day -1, 1, 5, 9, 13, 17
|
Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing.
Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.
Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose.
Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.
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Day -1, 1, 5, 9, 13, 17
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Incidence of Treatment-Emergent Adverse Events
Tidsramme: 8 weeks
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8 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: J Hall, MD, Ardea Biosciences, Inc.
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)
1. maj 2015
Primær færdiggørelse (Faktiske)
26. juni 2015
Studieafslutning (Faktiske)
29. januar 2016
Datoer for studieregistrering
Først indsendt
30. april 2015
Først indsendt, der opfyldte QC-kriterier
15. maj 2015
Først opslået (Skøn)
19. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RDEA3170-111
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
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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