This open-label, two-period, fixed-sequence study will investigate the pharmacokinetics and safety of multiple doses of aleglitazar on a single dose of digoxin in healthy volunteers. In period 1, volunteers will receive a single dose of digoxin, in period 2 volunteers will receive multiple doses of aleglitazar and a single dose of digoxin. The anticipated time on study treatment is one month.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
28
Multiple doses of aleglitazar
Single dose of digoxin
Unnamed facility
Manchester, United Kingdom
Pharmacokinetics: Area under the concentration time curve
Time frame: Approximately 1 month
Pharmacokinetics: maximum plasma concentration
Time frame: Approximately 1 month
Pharmacokinetics: Elimination half-life
Time frame: Approximately 1 month
Pharmacokinetics: Time to maximum plasma concentration
Time frame: Approximately 1 month
Pharmacokinetics: Renal clearance
Time frame: Approximately 1 month
Pharmacokinetics: Apparent volume of distribution
Time frame: Approximately 1 month
Pharmacokinetics: Apparent clearance
Time frame: Approximately 1 month
Pharmacokinetics: Amount excreted in the urine
Time frame: Approximately 1 month
Pharmacokinetics: Fraction of drug excreted in urine
Time frame: Approximately 1 month
Safety: Incidence of adverse events
Time frame: Approximately 2 months
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