Trial Outcomes & Findings for Pharmacokinetic Study of an Acute Gout Regimen (NCT NCT01017042)

NCT ID: NCT01017042

Last Updated: 2009-11-20

Results Overview

The maximum or peak concentration that the drug reaches in the plasma.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).
• Results posted on: 2009-11-20

Participant Flow

Participant milestones

Measure	Oral Colchicine 1.2mg + 0.6mg On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacokinetic Study of an Acute Gout Regimen

Baseline characteristics by cohort

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 Participants On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	28.9 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

The maximum or peak concentration that the drug reaches in the plasma.

Outcome measures

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 Participants On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.	Corrected QTc Interval (0.5 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (0.5hour)	Corrected QTc Interval (1 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (1 hour)	Corrected QTc Interval (2 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (2 hour)	Corrected QTc Interval (4 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (4 hour)
Maximum Plasma Concentration	6192.77 picograms/ml Standard Deviation 2433.7	—	—	—	—

PRIMARY outcome

Timeframe: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

The area under the plasma concentration versus time curve beginning from the first dose until the last quantifiable concentration (96hours), calculated by the linear trapezoidal rule.

Outcome measures

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 Participants On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.	Corrected QTc Interval (0.5 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (0.5hour)	Corrected QTc Interval (1 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (1 hour)	Corrected QTc Interval (2 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (2 hour)	Corrected QTc Interval (4 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (4 hour)
Area Under the Concentration Time Curve From Time Zero to the Time of Last Measured Concentration (96 Hours) (AUC 0-t)	43787.55 pg-hr/ml Standard Deviation 11437.48	—	—	—	—

PRIMARY outcome

Timeframe: Pharmacokinetic samples collected pre-dose and 0.5, 1 hour (prior to the second dose), and 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours post-dose (relative to the first dose) and 72 and 96 hours post-dose (on an outpatient basis).

The area under the plasma concentration versus time curve extrapolated to infinity.

AUC∞ is calculated as the sum of Total AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant

Outcome measures

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 Participants On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.	Corrected QTc Interval (0.5 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (0.5hour)	Corrected QTc Interval (1 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (1 hour)	Corrected QTc Interval (2 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (2 hour)	Corrected QTc Interval (4 Hour) colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (4 hour)
Area Under The Concentration Time Curve From Zero Through Infinity (AUC∞)	52070.06 pg-hr/ml Standard Deviation 13689.27	—	—	—	—

SECONDARY outcome

Timeframe: Measured at baseline, 0.5, 1, 2, and 4 hours

Population: All participants

Corrected QT interval by Fridericia's formula -Measured at baseline, 0.5, 1, 2, and 4 hours

Outcome measures

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 Participants On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.	Corrected QTc Interval (0.5 Hour) n=13 Participants colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (0.5hour)	Corrected QTc Interval (1 Hour) n=13 Participants colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (1 hour)	Corrected QTc Interval (2 Hour) n=13 Participants colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (2 hour)	Corrected QTc Interval (4 Hour) n=13 Participants colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia's formula (4 hour)
Electrocardiogram Corrected QT Interval (QTcF)	402.28 Milliseconds Standard Deviation 19.66	397.38 Milliseconds Standard Deviation 18.37	399.26 Milliseconds Standard Deviation 20.59	401.51 Milliseconds Standard Deviation 20.64	402.38 Milliseconds Standard Deviation 23.16

Adverse Events

Oral Colchicine 1.2mg + 0.6mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oral Colchicine 1.2mg + 0.6mg n=13 participants at risk On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
Gastrointestinal disorders Abdominal Pain , Upper	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Diarrhea	15.4% 2/13 • Number of events 2
Gastrointestinal disorders Dyspepsia	7.7% 1/13 • Number of events 1
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1
Nervous system disorders Headache	15.4% 2/13 • Number of events 2
Vascular disorders Hot Flush	7.7% 1/13 • Number of events 1

Additional Information

Medical Director

Mutual Pharmaceutical Company, Inc.

Phone: 215-697-1743

Email: clinicaltrials@urlmutual.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60