Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT02447601|
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : January 24, 2017
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatin(as determined by simvastation acid) in healthy subjects.
To assess the safety of single doses of simvastation administered with and without PEX168
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: PEX168 Drug: Simvastatin||Phase 1|
This was an open-label, sequential, single-center study that evaluated the pharmacokinetics of simvastatin when coadministered with PEX168 in healthy adult subjects. The total duration of each subject's participation in the study was approximately 10 weeks, which included up to a 14-day Screening Period, a 34-day Treatment Period, and an approximately 4-week Follow-up Period.
Center: This study was conducted at a single site in Shanghai Mental Health Center (SMHC)of China Treatment.All subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label,Sequential,Single-site Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Polyethylene Glycol Loxenatide (PEX168) in Healthy Adult Subjects|
|Actual Study Start Date :||March 30, 2015|
|Actual Primary Completion Date :||May 14, 2015|
|Actual Study Completion Date :||August 11, 2015|
Experimental: Simvastatin and PEX168(200µg)
Simvastatin: 40mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week.
200µg,injected subcutaneously,once a week.
Other Name: Polyethylene Glycol Loxenatide
Other Name: Shujiangzhi
- Plasma concentrations of simvastatin and simvastatin acid. [ Time Frame: Baseline to Day34 ]Plasma concentrations of simvastatin and simvastatin acid, and to calculate the pharmacokinetic parameters: Tmax, Cmax, AUC0-t, AUC0-∞, λz, t1 / 2, Vd / F, CL / F, etc.
- Incidence of adverse events and serious adverse events [ Time Frame: Baseline to Day67 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447601
|Shanghai Mental Health Center (SMHC)|
|Shanghai, Shanghai, China, 200122|
|Principal Investigator:||Huafang Li, MD||Shanghai Mental Health Center (SMHC)|