A Study of the Excretion Balance of Radiocarbon and the Pharmacokinetics and Metabolic Profile of TRO19622 (Olesoxime)
14. juli 2016 oppdatert av: Hoffmann-La Roche
A Single-Center, Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labeled TRO19622 and Its 14C-Metabolites) and to Investigate the Pharmacokinetics and Metabolic Profile of TRO19622
This Phase I study is designed to determine the excretion balance of radiocarbon, as the sum of carbon-14 (14C)-labeled TRO19622 and its 14C-metabolites, and to investigate the pharmacokinetics and metabolic profile of TRO19622 (olesoxime) in healthy participants.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- Body mass index (BMI) 20.0 to 28.0 kilograms per meter-squared (kg/m^2) and body weight at least 60 kilograms (kg)
- Fitzpatrick skin type less than (<) 4
- Good health according to medical history, physical examination, laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG)
- Negative urine test for drugs of abuse
- Negative alcohol breath test
- Negative tests for hepatitis or human immunodeficiency virus (HIV)
- Use of effective contraception during and for 3 months beyond study participant, among sexually active non-vasectomized participants with females partners of childbearing potential
Exclusion Criteria:
- Concomitant or recent medication use within 2 weeks prior to Day 1, except for paracetamol
- Use of enzyme-inducing drugs within 2 months prior to Day 1
- Any medical condition that may alter the pharmacokinetics of olesoxime or affect interpretation of study results
- Irregular bowel movements
- Drug addiction or alcoholism
- Use of nicotine products
- Participation in another clinical study within 12 weeks prior to Day 1
- Exposure to ionizing radiation within one year prior to Day 1
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Olesoxime
Participants will receive a single dose of liquid suspension of 14C-labeled olesoxime containing an equivalent of 600 milligrams (mg) of the compound.
The total amount of administered radiocarbon will be 93 microcuries (mcCi), or 3.447 megabecquerels (MBq).
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Olesoxime will be given orally on Day 1 as a 600-mg liquid suspension within 30 minutes after starting a standardized high-fat breakfast.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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T1/2 of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Apparent Plasma Clearance (CL/F) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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CL/F of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Apparent Volume of Distribution (Vz/F) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Vz/F of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Cumulative Amount of Olesoxime Excreted in Urine
Tidsramme: Continuous urine collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
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Continuous urine collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
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Cumulative Amount of Olesoxime Excreted in Expired Air
Tidsramme: Pre-dose (0 h) and post-dose (8, 10, 12, 16, 24, 48, 72, 96 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (8, 10, 12, 16, 24, 48, 72, 96 h) following single dose on Day 1
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Cumulative Amount of Olesoxime Excreted in Feces
Tidsramme: Continuous fecal collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
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Continuous fecal collection from pre-dose (0 h) to post-dose (432 h, or until release criteria are met) following single dose on Day 1
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Renal Clearance (CLr) of Olesoxime
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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AUClast of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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AUCinf of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Percentage of Participants with Adverse Events (AEs)
Tidsramme: Continuously from Screening until 7 days after last dose (up to 46 days overall)
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Continuously from Screening until 7 days after last dose (up to 46 days overall)
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Maximum Observed Concentration (Cmax) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 hours [h]) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 hours [h]) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Cmax of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Time of Maximum Observed Concentration (Tmax) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Tmax of Radiocarbon
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 168, 216, 264, 312, 360, 408 h) following single dose on Day 1
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Area Under the Concentration-Time Curve from Drug Administration to Last Quantifiable Concentration (AUClast) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Area Under the Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Elimination Half-Life (t1/2) of Olesoxime and Any Major Metabolite(s) Identified
Tidsramme: Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Pre-dose (0 h) and post-dose (2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408 h) following single dose on Day 1
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Samarbeidspartnere og etterforskere
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Sponsor
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2014
Primær fullføring (Faktiske)
1. september 2014
Studiet fullført (Faktiske)
1. september 2014
Datoer for studieregistrering
Først innsendt
14. juli 2016
Først innsendt som oppfylte QC-kriteriene
14. juli 2016
Først lagt ut (Anslag)
18. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- WP29867
- 2014-002470-37 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .