Who is sponsoring NCT01959594?

NCT01959594 is sponsored by Pfizer.

What drugs are being tested in NCT01959594?

Interventions: 3 mg PF-06412562, 10 mg PF-06412562, 25 mg PF-06412562, PF-06412562 TBD mg, PF-06412562 TBD mg.

What is the status of NCT01959594?

NCT01959594 is currently COMPLETED.

Last reviewed 2014-03-27 · How we verify

Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Dose Escalation, Parallel Group Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Repeat Doses Of PF-06412562 In Healthy Subjects

NCT01959594 Phase 1 COMPLETED

This study is designed to evaluate the safety and plasma concentrations of PF-06412562 in healthy volunteers following three times daily oral dosing of PF-06412562 for 14 days

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	40
Start date	2013-11
Completion	2014-03

Conditions

Healthy

Interventions

3 mg PF-06412562
10 mg PF-06412562
25 mg PF-06412562
PF-06412562 TBD mg
PF-06412562 TBD mg

Primary outcomes

Safety and toleration assessed by: adverse events, supine and standing vital sign measurements, electrocardiogram (ECG) standard 12 lead, blood and urine safety laboratory tests ,CogState and C-SSRS. — 0-15 days
Pharmacokinetics: Cmax, Tmax, AUCτ Ctrough, PTR, Rac on Cmax and AUCτ t1/2, CL/F, PTR, — 0-15 days
CogState at followup — 22-25 days

Countries

United States