Healthy Volunteer
Conditions
Keywords
Dose proportionality on the pharmacokinetics, Dose proportionality on the safety and tolerability, Atirmociclib (PF-07220060)
Brief summary
The purpose of this clinical trial is to learn about the dose proportionality on the PK of the study medicine (called atirmociclib) when administered in the various doses range under the fed condition in healthy participants. This study is seeking participants who are: 1. male and female aged 18 to 65 years are healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests 2. with BMI of 17.5-30.5 kg/m2; and a total body weight \>50 kgs (110 lbs.). All participants (72 total) in this study will receive atirmociclib at Dose (A), Dose (B), Dose (C), and Dose (D) oral dose in 1 of the 12 treatment sequences among 6 cohorts under fed conditions. Atirmociclib will be given by mouth at the study research unit once single dose about 30 minutes after a moderate fat standard calorie meal. Dose proportionality will be evaluated on the pharmacokinetics (PK), safety and tolerability of atirmociclib at Doses (A), (B), (C), and (D) oral dose under the fed condition. Including the 28 days of screening window and the 35 days safety follow-up period, the total study duration for each participant can be up to 71 days, containing 2 periods (6 days for each period), minimum 7-day interval between two periods, and follow-up period 28 to 35 days from administration of the final dose of study intervention. During this time, they will undergo safety laboratory and serial blood PK samplings up to 120 hours after administration of atirmociclib to determine plasma concentrations of atirmociclib. Participants will be discharged from the research unit on Period 2 Day 6 following completion of all assessments.
Interventions
DRUGatirmociclib (PF-07220060)
Open-label, two-period, cross-over study to evaluate dose proportionality of atirmociclib (PF-07220060) pharmacokinetics when administered under fed condition to healthy participants
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1, open-label, randomized, two-period, cross-over study to evaluate the dose proportionality on the pharmacokinetics, safety, and tolerability
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests. * Body mass Index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb.). Exclusion: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. * Concomitant use of any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 are prohibited within 5 half-lives plus 14 days (up to 28 days) prior to first dose of atirmociclib. * Previous exposure to atirmociclib or participation in studies requiring atirmociclib administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 1 hour prior to atirmociclib dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose | Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated) |
| Maximum Observed Plasma Concentration (Cmax) | 1 hour prior to atirmociclib dosing, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment | Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35 |
| Number of Participants With Laboratory Abnormalities | Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35 |
| Number of Participants With Abnormalities in Physical Examination | Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35 |
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings | Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35 |
| Number of Participants With Concomitant Medications | Period 1: Days 1-6; minimum 7-day interval between two doses; Period 2: Day 1-35 |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed