Healthy Clinical Trial
Official title:
A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF REPEAT-DOSE RIFAMPIN ON THE PHARMACOKINETICS OF PF-04965842 IN HEALTHY SUBJECTS
This is a Phase 1 open label, 2 period, single fixed sequence study designed to evaluate the
effect of repeat dose oral rifampin on single dose PF 04965842 PK after a single 200 mg oral
dose in healthy subjects. A total of 12 healthy male and/or female subjects will be enrolled
in the study so that at least 10 subjects will complete the study.
Subject will report to the clinical research unit (CRU) at least 12 hours prior to Day 1
dosing in Period 1 and will be required to stay in the CRU for 11 days and 10 nights.
Genotyping samples for CYP2C19 and CYP2C9 will be collected predose in Period 1 only. In
Period 1, subjects will be administered a single oral 200 mg dose of PF 04965842 in the
morning on Day 1 under fasted conditions. No food will be allowed for at least 4 hours
postdose and undergo serial blood sample collection for 24 hours postdose to characterize the
PK profile of PF 04965842.
In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7,
approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight
fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to
administration of a single 200 mg oral dose of PF 04965842. Subjects will remain in a fasted
state for 4 hours after dosing with PF 04965842 and undergo serial blood sample collection
for 24 hours post PF 04965842 dosing to characterize the PK profile of PF 04965842. Subjects
will be discharged from the CRU on Day 9 of Period 2 after all study procedures are
completed. The subject will be required to return to the CRU for on site follow up visits 7
14 days, and have a follow up phone contact 28 35 days after the last dose of PF 04965842.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |