New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
NCT Number: NCT01989143
This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06511, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.
Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 6 weeks
Time frame: 6 weeks
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: 6 weeks
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 6 weeks
Time frame: 6 weeks
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 6 weeks
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: 6 weeks
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 6 weeks
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 6 weeks
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 6 weeks
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: 6 weeks
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: 6 weeks
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Time frame: 6 weeks
Telavant, Inc.
Industry
A Phase 1, Randomzied, Double-blind, Third-party Open Placebo-controlled, Dose Escalating Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Intravenous And Multiple Subcutaneous And Intravenous Doses Of Pf-06480605 In Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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