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- Klinische proef NCT02336594
RDEA3170 Bioavailability Study
9 oktober 2017 bijgewerkt door: Ardea Biosciences, Inc.
A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet.
This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
15
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Texas
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Austin, Texas, Verenigde Staten, 78744
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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 ≤ 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 (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture
- Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)
- Subject cannot swallow multiple tablets
- Subject is a heavy caffeine drinker
- Subject is unwilling to comply with the dietary restrictions of the study
- Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Sequence ABCD
2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.
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Experimenteel: Sequence BACD
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat
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Experimenteel: Sequence ABDC
2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
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Experimenteel: Sequence BADC
10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Maximum Observed Plasma Concentration (Cmax)
Tijdsspanne: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Cmax of RDEA3170 in fasted condition.
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Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Time of Occurrence of Maximum Observed Concentration (Tmax)
Tijdsspanne: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Tmax of RDEA3170 following various treatments.
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Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
Tijdsspanne: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC last of RDEA3170 in fasted condition.
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Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
Tijdsspanne: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC∞ of RDEA3170 the fasted condition.
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Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Apparent Terminal Half-life (t1/2)
Tijdsspanne: Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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t1/2 of RDEA3170 following various treatments.
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Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Cmax of RDEA3170 in high-fat fed state.
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Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC last of RDEA3170 in high-fat fed state.
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Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC∞ of RDEA3170 in high-fat fed state.
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Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Cmax of RDEA3170 in low-fat fed state.
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Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC last of RDEA3170 in low-fat fed state.
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Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets
Tijdsspanne: Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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AUC∞ of RDEA3170 in low-fat fed state.
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Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine
Tijdsspanne: Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.
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PD profiles of uric acid from serum and urine.
PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.
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Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.
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Incidence of Treatment-Emergent Adverse Events
Tijdsspanne: 7 weeks.
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7 weeks.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: J. Hall, MD, Ardea Biosciences, Inc.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2014
Primaire voltooiing (Werkelijk)
1 januari 2015
Studie voltooiing (Werkelijk)
1 maart 2015
Studieregistratiedata
Eerst ingediend
6 november 2014
Eerst ingediend dat voldeed aan de QC-criteria
9 januari 2015
Eerst geplaatst (Schatting)
13 januari 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
9 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RDEA3170-110
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op RDEA3170 10 mg
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Ardea Biosciences, Inc.Voltooid
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Ardea Biosciences, Inc.Voltooid
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Ardea Biosciences, Inc.Voltooid
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Ardea Biosciences, Inc.Voltooid
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Hanmi Pharmaceutical Company LimitedVoltooidPrimaire hypercholesterolemieKorea, republiek van
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Vigonvita Life SciencesVoltooidFarmacodynamische studie van TPN171H-tabletten bij patiënten met milde tot matige erectiestoornissenErectiestoornissenChina
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AstraZenecaVoltooidZollinger-Ellison-syndroom | Reflux-oesofagitis (RE) | Maagzweer (GU) | Twaalfvingerige darmzweer (DU) | Naadzweer (AU) | Niet-erosieve reflux-oesofagitisziekte (NERD)Japan
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Yokohama City UniversityWerving
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The Netherlands Cancer InstituteVoltooid