NCT02817243

Brief Summary

The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

June 29, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

June 27, 2016

Last Update Submit

June 28, 2016

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (6)

  • The maximum plasma concentration (Cmax) of SP2086

    Cmax (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.

    up to Day 9

  • The maximum plasma concentration (Cmax) of SP2086 acid

    Cmax (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.

    up to Day 9

  • The maximum plasma concentration (Cmax) of Simvastatin

    Cmax (a measure of the body's exposure to Simvastatin) will be compared. before and after administration of multiple doses of SP2086

    up to Day 9

  • The area under the plasma concentration-time curve (AUC) of SP2086

    AUC (a measure of the body's exposure to SP2086) will be compared before and after administration of a single dose of Simvastatin.

    up to Day 9

  • The area under the plasma concentration-time curve (AUC) of SP2086 acid

    AUC (a measure of the body's exposure to SP2086 acid) will be compared before and after administration of a single dose of Simvastatin.

    up to Day 9

  • The area under the plasma concentration-time curve (AUC) of Simvastatin

    AUC (a measure of the body's exposure to Simvastatin) will be compared before and after administration of multiple doses of SP2086.

    up to Day 9

Secondary Outcomes (1)

  • The number of volunteers with adverse events as a measure of safety and tolerability

    up to Day 9

Study Arms (1)

SP2086 and Simvastatin

OTHER

SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Drug: SP2086Drug: Simvastatin

Interventions

SP2086DRUG

SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

SP2086 and Simvastatin
SimvastatinDRUG

SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

SP2086 and Simvastatin

Eligibility Criteria

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

You may qualify if:

  • Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

You may not qualify if:

  • History of diabetes
  • History of heart failure or renal insufficiency
  • Urinary tract infections, or vulvovaginal mycotic infections
  • History of or current clinically significant medical illness as determined by the Investigator
  • History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
  • Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or Simvastatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hosital of Jilin University

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

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

Study Record Dates

First Submitted

June 27, 2016

First Posted

June 29, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Last Updated

June 29, 2016

Record last verified: 2016-03

Locations

CN(1)