Phase 1 N=18 Randomized Treatment

A Food-Drug Interaction Study of Serum Urate After Oral Inosine

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02614469 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Cmax: Maximum Observed Serum Urate Concentration — 6.6; 6.4 mg/dL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Inosine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Michael Alan Schwarzschild
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax: Maximum Observed Serum Urate Concentration	6.6; 6.4	—
PRIMARY AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration)	267; 268	—
PRIMARY AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity	2040; 2031	—
PRIMARY Tmax: Time of Maximum Serum Concentration	3.0; 3.0	—
PRIMARY T1/2: Apparent Terminal Half-life	242; 241	—
PRIMARY Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration	1.73; 1.65	—
PRIMARY Baseline Corrected AUC (0-t): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Serum Concentration)	36.1; 39.3	—
PRIMARY Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity	80.4; 83.0	—
PRIMARY Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration	3.0; 3.0	—
PRIMARY Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life	44.3; 44.7	—
SECONDARY Safety Assessment (Vital Signs)	0; 0	—
SECONDARY Safety Assessment: Adverse Events	0; 0	—

Summary

The purpose of this study is to assess the effects of food on the amount of urate in the body after a single oral dose of inosine.

Eligibility Criteria

Inclusion Criteria

Healthy male subjects between the ages of 18 and 65 years
Body-mass index between 18.0 kg/m2 and 32.0 kg/m2
If not surgically sterile, willing to refrain from donating sperm and willing to use appropriate birth control when engaging in sexual intercourse for a period of 90 days following the last dose of the study medication
Serum urate < 6.1 mg/dL (approximately 360 μM) at screening
Non-smokers for at least 6 months prior to screening
Adequate venous access at multiple sites in both arms

Exclusion Criteria

History of alcohol or drug dependence in the past 2 years
Had 400 mL of whole blood collection within four months or 200 mL of whole blood collection or who had blood component collection within one month of the screening test
Used prescription or over-the-counter (OTC) drugs within 14 days prior to screening
Used vitamin preparations or supplements (including St. John's Wort and ginseng) within 28 days prior to the screening test
Not willing to refrain from alcohol, grapefruit, grapefruit juice or related products, caffeine consumption (including chocolate), and strenuous exercise within 72 h prior to day 1 and through the end of the PK study
Treated with an investigational drug within 30 days or 7 half-lives of the investigational drug, whichever is longer, prior to the first dose of study drug
Previously received inosine supplement within three months from the screening or subjects who have had any inosine and suffered an adverse reaction due to it
Known HIV disease
Had a febrile illness within 5 days prior to the first dose of study medication
Vaccinated within 30 days prior to the first dose of medication
Has gout or a history or suspicion of kidney stones
Determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02614469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.