NCT02447601

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 30, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2015

Completed
Last Updated

January 24, 2017

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

March 25, 2015

Last Update Submit

January 21, 2017

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of simvastatin and simvastatin acid.

    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.

    Baseline to Day34

Secondary Outcomes (1)

  • Incidence of adverse events and serious adverse events

    Baseline to Day67

Study Arms (1)

Simvastatin and PEX168(200µg)

EXPERIMENTAL

Simvastatin: 40mg, oral Administration. PEX 168: 200µg,injected subcutaneously,once a week.

Drug: PEX168Drug: Simvastatin

Interventions

PEX168DRUG

200µg,injected subcutaneously,once a week.

Also known as: Polyethylene Glycol Loxenatide
Simvastatin and PEX168(200µg)
SimvastatinDRUG

40mg,oral,two times

Also known as: Shujiangzhi
Simvastatin and PEX168(200µg)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • An individual who met all of the following criteria was eligible for the study.
  • Healthy male aged 18 to 45 years (including both ends) at the time of signing the informed consent.
  • Weighing not less than 50kg，Body Mass Index (BMI)of 18 to 25kg/m2.
  • No history of cardiovascular, liver, kidney, gastrointestinal, neuropsychiatric and other diseases, no history of drug allergy.
  • Capable of giving written informed consent, which included compliance with the requirements and restrictions listed in the consent form.

You may not qualify if:

  • Known for any study drug allergy (PEX168, simvastatin) or similar drug allergy (GLP-1 receptor agonists, GLP-1 analogue, statins) or allergic constitution;
  • Having Alcohol and drug abuse within first 6 months before screening;
  • Smoked within 3 months before screening;
  • Received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors, or any other similar structure drug for treatment before screening;
  • Following a thorough medical examination, clinically significant abnormalities were found;
  • In screening period, blood pressure greater than 140 / 90mmHg, retest after diagnosis or pulse rate is higher than 100bpm person;
  • In screening period, ECG QTc\> 450ms, diagnosed after retest;
  • In screening period, serum creatinine or urine protein is abnormal, and were determined to be clinically significant by the investigator;
  • In screening period, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), γ- glutamate GGT (γ-GT), total bilirubin (Tbil) is greater than the normal range limit, and investigator determines to have clinical significance;
  • In screening period, creatine kinase (CK) exceeds the upper limit of the normal range, and judged by the investigator to be clinical significant;
  • In screening period, having thyroid dysfunction;
  • Before screening there is a history of medullary thyroid cancer;
  • Having any surgery (including the impact of gastric emptying of gastrointestinal surgery) within 6 months before screening;
  • Participate in blood donation and donation amount ≥400ml within three months before screening, or who participate in blood donation or blood transfusion within a month;
  • Using any of the tested drugs may affect prescription drugs, nonprescription drugs, herbs, food (such as grapefruit juice) or food supplements persons 2 weeks before screening;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center (SMHC)

Shanghai, Shanghai Municipality, 200122, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

polyethylene glycol loxenatideSimvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Huafang Li, MD

    Shanghai Mental Health Center (SMHC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

May 19, 2015

Study Start

March 30, 2015

Primary Completion

May 14, 2015

Study Completion

August 11, 2015

Last Updated

January 24, 2017

Record last verified: 2015-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)