Single Dose Study of PF-06815345 in Healthy Subjects
- Registration Number
- NCT02654899
- Lead Sponsor
- Pfizer
- Brief Summary
The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Healthy males and female of non-childbearing potential;
- Age of 18-55, inclusive;
- Body Mass Index 17.5-34.9 kg/m2, inclusive;
- Body weight >50 kg;
- Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1_Cohort 2_Placebo Placebo Single dose of placebo Part 1_Cohort 1_Placebo; Placebo Single dose of placebo Part 1_Cohort 1_Active; PF-06815345 Single ascending dose of PF-06815345 Part 2 PF-06815345 Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345 Part 1_Cohort 2_Active PF-06815345 Single ascending dose of PF-06815345
- Primary Outcome Measures
Name Time Method Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) Baseline (Day 0) up to 28 days after last dose of study medication Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Maximum Observed Plasma Concentration (Cmax)
Apparent Oral Clearance (CL/F) for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose 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. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701) 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Apparent Volume of Distribution (Vz/F) for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose 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 to Reach Maximum Observed Concentration for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Time to Reach Maximum Observed Plasma Concentration (Tmax)
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701) 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701) 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Time to Reach Maximum Observed Plasma Concentration (Tmax)
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701) 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Plasma Decay Half-Life (t1/2)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2) for PF-06815345 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose Plasma Decay Half-Life (t1/2)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701) 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium