A Single Dose Study of SHR4640 in Healthy Male Volunteers

NCT03015948 | Completed Phase 1

• 1 other identifier: SHR4640-101-AUS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Assess safety and tolerability of SHR 4640 over 11days including AEs, laboratory safety variables (including hematology, creatinine kinase (CK), biochemistry, and urinalysis), physical examinations, vital signs, and 12-lead electrocardiograms (ECGs)

  11 days

Secondary Outcomes (8)

• Assess Pharmacokinetics (PK) Plasma parameter Area under the concentration-time curve (AUC) from zero to 24 and 72 hours postdose and from zero to infinity.

  from time of dosing to 72 hours

• Assess Pharmacokinetics (PK) Plasma parameter Time to maximum concentration.

  from time of dosing to 72 hours

• Assess Pharmacokinetics (PK) Plasma parameter Maximum concentration.

  from time of dosing to 72 hours

• Assess Pharmacokinetics (PK) Plasma parameter Terminal elimination half-life (T1/2).

  from time of dosing to 72 hours

• Assess Pharmacodynamics (PD) parameter Actual and percent changes in serum uric acid (sUA )from baseline.

  from time of dosing to 72 hours

Study Arms (5)

2.5mg SHR4640

EXPERIMENTAL

10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 2.5 mg SHR4640 (n=8) or placebo (n=2)

Drug: SHR4640

10mg SHR4640

EXPERIMENTAL

10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 10mg SHR4640 (n=8) or placebo (n=2) 10mg.

Drug: SHR4640

20mg SHR4640

EXPERIMENTAL

10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 20mg SHR4640 (n=8) or placebo (n=2) .

Drug: SHR4640

Placebo

EXPERIMENTAL

For each dose cohort, 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2)

Drug: Placebo

5mg SHR4640

EXPERIMENTAL

10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 5 mg SHR4640 (n=8) or placebo (n=2)

Drug: SHR4640

Interventions

SHR4640 DRUG

a single dose of SHR4640 (n=8) for each dose cohort

10mg SHR4640; 2.5mg SHR4640; 20mg SHR4640; 5mg SHR4640

Placebo DRUG

a single dose of placebo (n=2) for each dose cohort .

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, aged between 18 and 55 years, inclusive.
• Body weight ≥ 50 kg and body mass index between 18.0 to 30.0 kg/m2, inclusive.
• Screening sUA level from 0.24 to 0.42 mmol/L, inclusive.
• Considered generally healthy upon completion of medical history, full physical examination, vital signs, laboratory parameters (including thyroid function, coagulation and serological tests, hematology, creatinine kinase, biochemistry, and urinalysis), 12-lead ECG, and abdominal ultrasound, as judged by the Investigator.
• Agrees to use a highly effective method of contraception, i.e. condom and suitable contraception for your female partner e.g. diaphragm (double barrier), oral contraceptive or intrauterine contraceptive device during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence throughout the study period and for 30 days following study drug dosing, and must agree to refrain from sperm donation from Day -2 until at least 30 days following study drug dosing.
• Negative drug screen (including alcohol) at screening and on admission to clinical site.
• Able to understand the study procedures and the risks involved and must be willing to provide written informed consent before any study-related activity.

You may not qualify if:

• History of hypersensitivity to SHR4640 or its analogues.
• Screening sCr above upper limit of normal.
• Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase \> 1.5 × upper limit of normal.
• Positive result for HIV.
• Positive result for hepatitis B surface antigen or hepatitis C virus antibody.
• History or presence of kidney stones.
• Acute or chronic illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject.
• Undergone major surgery within 3 months of Day 1.
• Donated any blood or plasma in the past month or more than 400 mL within 3 months of Day 1.
• Has poor venous access and is unable to donate blood.
• Use of tobacco products within 30 days of Day 1.
• Heavy caffeine drinker (more than 5 cups or glasses of caffeinated beverages per day).
• History of drug and/or alcohol abuse in the last year.
• Consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz of beer, or 1.5 oz of hard liquor).
• Consumes grapefruit and/or poppy seed within 5 days of Day 1.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Atridia Pty Limited

Sydney, New South Wales, 2000, Australia

Location

MeSH Terms

Conditions

Gout

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sam Salman, B.Sc,BMBS

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: January 10, 2017
• Study Start: September 22, 2016
• Primary Completion: November 23, 2016
• Study Completion: November 23, 2016
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)