A Study to Assess the Relative Bioavailability of JNJ-42756493 Tablets
28 oktober 2015 uppdaterad av: Janssen Research & Development, LLC
Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets
The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
This is an open-label (all people know the identity of the intervention), multi-period, randomized (study drug assigned by chance), single-dose, 3-way crossover study.
The study consists of 21-day screening period, 3 open-label treatment periods with a minimum 21 (+-2)-day washout between doses, and end-of-study assessments 10 (+-2) days after the last dose.
The duration of study is approximately 3 months.
Participants will be randomized to 1 of 6 treatment sequences as follows: Treatment sequence 1=ABC, 2=BCA, 3=CAB, 4=ACB, 5=BAC AND 6=CBA.
Treatment A=JNJ-42756493 current clinical formulation, 10 milligrams (mg) (2 tablets of 5 mg each).
Treatment B= JNJ-42756493 Prototype Formulation I (G-025), 10 mg (2 tablets of 5 mg each) and Treatment C=JNJ-42756493 Prototype Formulation II (G-025), 10 mg (2 tablets of 5 mg each).
Blood samples will be collected to determine pharmacokinetic parameters.
Participants' safety will be monitored throughout the study.
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Merksem, Belgien
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 55 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Participants should be willing to adhere to the prohibitions and restrictions specified in this protocol
- Woman must be either: postmenopausal (greater than (>) 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (follicle stimulating hormone [FSH]) >40 international unit per litre [IU/L]); surgically sterile
- Woman must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
- Woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 3 months after receiving the last dose of study drug.
- Man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Exclusion Criteria:
- Participants with history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Participants with history or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Participants with clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
- Participants with clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at Day -1 of Period 1 as deemed appropriate by the investigator
- Participants with use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Treatment A, then Treatment B and then Treatment C
Participants will receive treatment A (JNJ-42756493 10 milligram [mg] tablet, current clinical formulation [G-018] which uses milled active pharmaceutical ingredient [API]) in period 1, treatment B (JNJ-42756493 10 mg tablet, Prototype Formulation I [G-025] which uses coarser API) in period 2 and then treatment C (JNJ-42756493 10 mg tablet, Prototype Formulation II [G-025] which uses coarser API) in period 3.
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JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
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Experimentell: Treatment B, then Treatment C and then Treatment A
Participants will receive treatment B in period 1, treatment C in period 2 and then treatment A in period 3.
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JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
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Experimentell: Treatment C, then Treatment A and then Treatment B
Participants will receive treatment C in period 1, treatment A in period 2 and then treatment B in period 3.
|
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
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Experimentell: Treatment A, then Treatment C and then Treatment B
Participants will receive treatment A in period 1, treatment C in period 2 and then treatment B in period 3.
|
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
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Experimentell: Treatment B, then Treatment A and then Treatment C
Participants will receive treatment B in period 1, treatment A in period 2 and then treatment C in period 3.
|
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
|
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Experimentell: Treatment C, then Treatment B and then Treatment A
Participants will receive treatment C in period 1, treatment B in period 2 and then treatment A in period 3.
|
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maximum Observed Plasma Concentration (Cmax) of JNJ-42756493
Tidsram: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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The Cmax is the maximum observed plasma JNJ-42756493 concentration.
Relative bioavailability will be calculated by Cmax based on total drug concentrations.
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Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24]) of JNJ-42756493
Tidsram: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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AUC(0-24) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to 24 hours.
Relative bioavailability will be calculated by AUC(0-24) based on total drug concentrations.
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Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (Clast) (AUC[0-last]) of JNJ-42756493
Tidsram: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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AUC(0-last) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to time of the last observed quantifiable concentration (Clast).
Relative bioavailability will be calculated by AUC(0-last) based on total drug concentrations.
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Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time AUC (infinity) of JNJ-42756493
Tidsram: Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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AUC (infinity) is the area under the plasma JNJ-42756493 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC(0-last) and Clast/lambda(z), in which lambda(z) is the first-order rate constant associated with the terminal portion of the curve.
Relative bioavailability will be calculated by AUC (infinity) based on total drug concentrations.
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Predose, 0.16 hour (hr),0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hr post-dose on Day 1; 24 and 36 hr post-dose on Day 2; 48hr post-dose on Day 3; 72hr post-dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6; 144hr post-dose on Day 7
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Tidsram: Screening up to end of study (up to 3 months)
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Screening up to end of study (up to 3 months)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2015
Primärt slutförande (Faktisk)
1 augusti 2015
Avslutad studie (Faktisk)
1 augusti 2015
Studieregistreringsdatum
Först inskickad
5 juni 2015
Först inskickad som uppfyllde QC-kriterierna
5 juni 2015
Första postat (Uppskatta)
9 juni 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
30 oktober 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 oktober 2015
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CR107460
- 42756493EDI1004 (Annan identifierare: Janssen Research & Development, LLC)
- 2015-001583-19 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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