RDEA3170 Tablet and Capsule Bioavailability Study
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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Texas
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Austin, Texas, Stati Uniti, 78744
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Treatment A
RDEA3170, 5 mg (FN24), administered in the fasted state.
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
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Sperimentale: Treatment B
RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
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Sperimentale: Treatment C
RDEA3170, 10 mg (FN25), administered in the fasted state.
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
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Sperimentale: Treatment D
RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
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Sperimentale: Treatment E
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Altri nomi:
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Sperimentale: Treatment I
RDEA3170, 10 mg (FN26), administered in the fasted state.
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Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Altri nomi:
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Sperimentale: Treatment J
RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).
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Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Altri nomi:
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Sperimentale: Treatment K
RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.
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Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
Altri nomi:
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: Day 1, 5, 9, 13, 17
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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)
Lasso di tempo: 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
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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∞)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Day 1, 5, 9, 13, 17
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AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Pharmacodynamics (PD) Profile of RDEA3170
Lasso di tempo: Day -1, 1, 5, 9, 13, 17
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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
Lasso di tempo: 8 weeks
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8 weeks
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: J Hall, MD, Ardea Biosciences, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- RDEA3170-111
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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