The DDI Study of SP2086 and Valsartan

NCT02817217 | Unknown Phase 1

• 1 other identifier: SP2086-111
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the potential PK interaction between SP2086 and Valsartan after multiple oral doses treatment in healthy male volunteers.

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 Valsartan

  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 Valsartan

  up to Day 9

• The maximum plasma concentration (Cmax) of Valsartan

  Cmax (a measure of the body's exposure to Valsartan) 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 Valsartan.

  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 Valsartan.

  up to Day 9

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

  AUC (a measure of the body's exposure to Valsartan) 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 Valsartan

OTHER

Drug: SP2086; Drug: Valsartan

Interventions

SP2086 DRUG

SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.

SP2086 and Valsartan

Valsartan DRUG

SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.

SP2086 and Valsartan

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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 Valsartan or any of the excipients of the formulation of SP2086 or Valsartan

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

People's Liberation Army General Hospital of Chengdu Military Region

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

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: 2016-01

Locations

CN (1)