Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07215078 · ClinicalTrials.gov registry record · Phase 1
Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants
A Phase 1 study of Healthy Volunteer, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT07215078: Recruiting Phase 1 study of Healthy Volunteer, sponsored by Pfizer.
NCT07215078 is a Phase 1 study of Healthy Volunteer that is actively recruiting participants, run by Pfizer. The registered enrollment target is 72 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215078, a Phase 1 study of Healthy Volunteer, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Dose-normalized plasma AUCinf and Cmax of atirmociclib for each cohort (AUClast if AUCinf cannot be estimated)
Conditions Studied
Interventions
- DRUG atirmociclib (PF-07220060)
Study Locations (1)
Connecticut
- Pfizer Clinical Research Unit - New Haven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-10-08 |
| Est. Completion | 2026-06-26 |
| Phase | Phase 1 |
What NCT07215078 shows while recruiting
NCT07215078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 1 intervention - of which atirmociclib (PF-07220060) is the first listed.
NCT07215078 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT07215078 about?
NCT07215078 is a clinical study titled "Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure as Dose Increases in Healthy Participants". 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 t...
What is the current status of trial NCT07215078?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2025-10-08. Estimated completion is 2026-06-26.
What conditions does trial NCT07215078 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT07215078?
The interventions under investigation include: atirmociclib (PF-07220060) (DRUG).
Who is sponsoring clinical trial NCT07215078?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07215078 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07215078's enrollment target sits among peer trials
72 48th of 112 higher than 62 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02359253 · 72 participants · NA
Robot Aided Rehabilitation - Intervention
- NCT02962661 · 72 participants · Phase 1
Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines
- NCT03113643 · 72 participants · Phase 1
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
- NCT03187535 · 72 participants · NA
Effect of TEAS on PONV After Spinal Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI