Drug Interaction Study of Colchicine and Theophylline
Condition: Healthy
Intervention: theophylline; colchicine
Intervention description: 300mg (80mg/15ml elixir); colchicine 0.6mg by mouth twice daily on Days 5-19, co-administered with theophylline 300mg (80mg/15ml) on the morning of Day 19
Intervention MeSH terms: Colchicine; Theophylline
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: pharmacokinetics; colchicine; theophylline

Summary:

      Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe
      substrate. When the two are co-administered the potential exists for a clinically significant
      drug interaction. This study aims to determine the effect of steady-state colchicine on the
      pharmacokinetics of theophylline administered as a single dose. A secondary goal is to
      evaluate the safety and tolerability of this regimen in healthy volunteers. All study
      subjects will be monitored for adverse events throughout the entire study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non smoking and non-pregnant (postmenopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive; hemoglobin
             greater than or equal to 11.5g/dL

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or donation of plasma

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  Subjects who test positive for drugs of abuse or alcohol at screening or check-in

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic,
             dermatologic, neurological, or psychiatric disease or active sexually transmitted
             disease

          -  History of neuropathy or muscle disorders, peptic ulcer disease, clinically
             significant cardiac arrhythmias, seizure disorder, and low white blood cell count or
             other bone marrow disorders

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  History of allergy or sensitivity to colchicine or theophylline or aminophylline

          -  Subjects who have had a tattoo or body piercing within 30 days prior to administration
             of study drug

          -  Subjects with irritable bowel syndrome, chronic diarrhea or other chronic
             gastro-intestinal problems

          -  Subjects who are lactose intolerant