MedDataX Logo

Trial Outcomes & Findings for A Food-Drug Interaction Study of Serum Urate After Oral Inosine (NCT NCT02614469)

NCT ID: NCT02614469

Last Updated: 2017-03-29

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

-12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose

Results posted on

2017-03-29

Participant Flow

Subjects took part in the study at one investigative site in the United States from 15 March 2016 to 10 April 2016.

Participant milestones

Participant milestones
Measure
Group 1, Inosine With Food Then Without Food
Group 1 subjects will take inosine with food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine without food on day 8 after an overnight fast. Inosine: Inosine, 1000 mg
Group 2, Inosine Without Food Then With Food
Group 2 subjects will take inosine without food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine with food on day 8 after an overnight fast. Inosine: Inosine, 1000 mg
Period 1
STARTED
9
9
Period 1
COMPLETED
9
9
Period 1
NOT COMPLETED
0
0
Period 2
STARTED
9
9
Period 2
COMPLETED
9
9
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1, Inosine With Food Then Without Food
n=9 Participants
Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast. Inosine: Inosine, 1000 mg
Group 2, Inosine Without Food Then With Food
n=9 Participants
Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast. Inosine: Inosine, 1000 mg
Total
n=18 Participants
Total of all reporting groups
Age, Continuous
41.44 years
STANDARD_DEVIATION 16.37 • n=5 Participants
34.67 years
STANDARD_DEVIATION 5.92 • n=7 Participants
38.06 years
STANDARD_DEVIATION 12.44 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Race/Ethnicity, Customized
White
5 participants
n=5 Participants
4 participants
n=7 Participants
9 participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
4 participants
n=5 Participants
4 participants
n=7 Participants
8 participants
n=5 Participants
Race/Ethnicity, Customized
Other
0 participants
n=5 Participants
1 participants
n=7 Participants
1 participants
n=5 Participants
Region of Enrollment
United States
9 participants
n=5 Participants
9 participants
n=7 Participants
18 participants
n=5 Participants

PRIMARY outcome

Timeframe: -12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Cmax: Maximum Observed Serum Urate Concentration
6.6 mg/dL
Standard Deviation 0.7
6.4 mg/dL
Standard Deviation 0.6

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration)
267 mg*hr/dL
Standard Deviation 30.2
268 mg*hr/dL
Standard Deviation 26.4

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Population: AUC (0-inf) of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.

Outcome measures

Outcome measures
Measure
Inosine Fed
n=17 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=17 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity
2040 mg*hr/dL
Standard Deviation 2261
2031 mg*hr/dL
Standard Deviation 2278

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Tmax: Time of Maximum Serum Concentration
3.0 hr
Interval 1.0 to 6.0
3.0 hr
Interval 1.0 to 24.0

PRIMARY outcome

Timeframe: -12 to 0 pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Population: T 1/2 of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.

Outcome measures

Outcome measures
Measure
Inosine Fed
n=17 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=17 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
T1/2: Apparent Terminal Half-life
242 hr
Standard Deviation 341
241 hr
Standard Deviation 331

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration
1.73 mg/dL
Standard Deviation 0.46
1.65 mg/dL
Standard Deviation 0.37

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
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 mg*hr/dL
Standard Deviation 15.1
39.3 mg*hr/dL
Standard Deviation 13.3

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose

Population: Baseline Corrected AUC (0-inf) values of 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.

Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).

Outcome measures

Outcome measures
Measure
Inosine Fed
n=16 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=16 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity
80.4 mg*hr/dL
Standard Deviation 84.2
83.0 mg*hr/dL
Standard Deviation 86.3

PRIMARY outcome

Timeframe: -12 to 0 h pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose

Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration
3.0 hr
Interval 1.0 to 6.0
3.0 hr
Interval 1.0 to 24.0

PRIMARY outcome

Timeframe: -12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose

Population: Baseline Corrected T 1/2 values for 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.

Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).

Outcome measures

Outcome measures
Measure
Inosine Fed
n=16 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=16 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life
44.3 hr
Standard Deviation 71.5
44.7 hr
Standard Deviation 76.2

SECONDARY outcome

Timeframe: Up to 10 days after first study drug administration at Day 1 of Period 1

Number of participants with clinically significant findings in vital signs by investigator after study drug administration.

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Safety Assessment (Vital Signs)
0 participants
0 participants

SECONDARY outcome

Timeframe: Up to 10 days after first study drug administration at Day 1 of Period 1

Number of participants with adverse events after study drug administration

Outcome measures

Outcome measures
Measure
Inosine Fed
n=18 Participants
Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Inosine Fasted
n=18 Participants
Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
Safety Assessment: Adverse Events
0 participants
0 participants

Adverse Events

Inosine Fed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Inosine Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Schwarzschild

Massachusetts General Hospital

Phone: 617-764-9611

Results disclosure agreements

  • Principal investigator is a sponsor employee All data and results and all intellectual-property rights in the data and results derived from the study will be the property of the sponsor. No publication or disclosure of study results will be permitted except as specified in a separate, written agreement between the Sponsor and the Investigator. If results of this study are reported in medical journals or at meetings, all subjects' identities will remain confidential.
  • Publication restrictions are in place

Restriction type: OTHER