- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02205905
An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects
19. maj 2020 opdateret af: Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects
This is an open-label, single-dose, non-randomized study in healthy male subjects to characterize the mass balance, metabolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Texas
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San Antonio, Texas, Forenede Stater, 78217
- Worldwide Clinical Trials Early Phase Services
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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
15 år til 55 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Male
- 18-55 years of age (inclusive)
- Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
- voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
- Willing and able to remain in the study unit for the entire duration of the confinement period
- Willing to collect all urine and fecal samples for the duration of the study period as required
- Will to eat entire meals and snacks provided during confinement at the research facility, and understand diet will include foods with high fiber content and possibly prune juice
- Willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required
- Willing to abstain from showering for the first 72 hours following study drug administration. After the restriction is lifted, willing to provide a urine sample prior to showering for the remainder of the confinement period.
Exclusion Criteria:
- History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
- Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
- History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
- Significantly abnormal diet within 4 weeks
- Donated blood or plasma within 30 days
- Participated in another clinical trial (randomized subjects only) within 30 days
- Participated in a radiolabeled clinical trial within the last 12 months
- Used any over-the-counter medication, including nutritional supplements, within 7 days
- Used any prescription medication within 14 days prior
- Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30 days
- Smoked or used tobacco products within 60 days
- History of substance abuse or treatment (including alcohol ) within the past 2 years
- Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
- Positive test for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus at screening or has previously been treated for hepatitis B, hepatitis C or HIV infection
- Has irregular bowel habits
- Has had significant radiation exposure within the prior 12 months
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 14C PER977
Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects
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Open-label, single dose
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mass balance of PER977 and metabolite
Tidsramme: 3 weeks
|
To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects
|
3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of subjects with adverse events
Tidsramme: 3 weeks
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To assess the safety and tolerability of a single intravenous dose of 200 mg PER977
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3 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cynthia A Zamora, MD, Worldwide Clinical Trials Early Phase Services
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
1. juli 2014
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
28. juli 2014
Først indsendt, der opfyldte QC-kriterier
31. juli 2014
Først opslået (Skøn)
1. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2020
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PER977-01-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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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