Phase 1
Completed N=13
Pharmacokinetic Study With Colchicine in Healthy Volunteers
Pharmacokinetics
Source: ClinicalTrials.gov NCT01017003 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Maximum Serum Concentration (Cmax) — 2450.15; 3553.15 pg/mL
Summary
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12 hours) in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Serum Concentration (Cmax) |
2450.15; 3553.15 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Time Zero to the Time of the Last Measured Level. |
10494.66; 43576.96 | — |
| PRIMARY Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-inf) |
12268.18; 54198.77 | — |
Eligibility Criteria
Inclusion Criteria
- Completion of the screening process within 28 days prior to Period I dosing
- Healthy non-smoking, non-obese adult men and women volunteers between the ages of 18 to 45 years of age, weighing at least 110 with a body mass index of 18-30kg/m2
- Women must be postmenopausal, surgically sterile, commit to abstinence from heterosexual sexual contact or use two methods of contraception.
Exclusion Criteria
- Pregnant or lactating
- Use of any investigational drug within 28 days prior to Period I dosing.
- Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s)
- Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Clinical laboratory test values outside the accepted reference range and when confirmed on re-examination.
- Any clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators)
- Use of any systemic prescription medication in the 14 days prior to Period I dosing
- History of any allergy(s) including allergy to colchicine or related drugs.
- History of drug or alcohol addiction or abuse within the past year or a positive drug abuse screen
- Currently or recent (within 6 months) use of tobacco products prior to dose administration
- Donation of greater than 150 mL of blood within 28 days or plasma within 14 days prior to period I dosing
Data sourced from ClinicalTrials.gov (NCT01017003). 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. Informational only — not medical advice.