- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00790556
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
- Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
- Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months
Exclusion Criteria:
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
- Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
- Subject has a history of contact lens use within approximately the previous 6 months
- Subject has been diagnosed with dry eye syndrome
- Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
- Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: 2
Placebo komparator
|
MK8245 placebo capsules twice daily for 13 days.
On Day 14, only the morning dose of study medication will be taken.
There will be a 14 day washout period.
Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days.
On Day 14, only the morning dose of study drug will be taken.
|
Eksperimentel: 1
MK8245
|
MK8245 50 mg capsules twice daily for 13 days.
On Day 14, only the morning dose of study medication will be taken.
There will be a 14 day washout period.
Patients will then crossover to MK8245 placebo capsules twice daily for 13 days.
On Day 14, only the morning dose of study drug will be taken.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
Tidsramme: 56 days
|
An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement. |
56 days
|
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
Tidsramme: Day 14 of each 14-day Treatment Period
|
Changes in HGP were determined during a euglycemic clamp procedure.
HGP was evaluated as milligrams per kilogram of glucose produced per minute.
|
Day 14 of each 14-day Treatment Period
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Hepatic Glucose Production (HGP) at Baseline
Tidsramme: Baseline
|
Baseline
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 8245-004
- 2008_582
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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