A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants

NCT04628793 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C45410012020-004280-42
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.

Conditions

Healthy Participants

Keywords

PF-07258669; first in human; melanocortin-4 receptor; MC4R; healthy participants; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.

  From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)

• Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)

  Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.

  From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)

• Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria

  Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of \>=20mmHg, standing systolic BP increase and decrease from BL of \>=30mmHg, supine diastolic BP increase and decrease from BL of \>=20mmHg, supine systolic BP increase and decrease from BL of \>=30mmHg.

  From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)

• Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria

  ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL \>200msec and max \>=25% increase from BL, or BL \<=200msec and max \>=50% increase from BL, QRS interval percent change from BL \>=50%, QTcF change from BL \>=30 and \<=60msec, or change from BL \>60msec.

  From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)

• Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings

  The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee).

  From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)

Secondary Outcomes (5)

• Maximum Observed Concentration (Cmax) of PF-07258669

  At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

• Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669

  At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

• Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669

  At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

• Time for Cmax (Tmax) of PF-07258669

  At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

• Terminal Half-life (t1/2) of PF-07258669

  At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4

Study Arms (3)

Cohort 1

EXPERIMENTAL

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Drug: PF-07258669; Drug: Placebo

Cohort 2

EXPERIMENTAL

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Drug: PF-07258669; Drug: Placebo

Cohort 3

EXPERIMENTAL

Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.

Drug: PF-07258669; Drug: Placebo

Interventions

PF-07258669 DRUG

PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Matching placebo will be prepared as an oral solution and/or suspension given in each cohort

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.
• Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

You may not qualify if:

• 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), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).
• Evidence of history of orthostatic hypotension or symptomatic bradycardia.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• Current findings or documented past history of blood pressure values \<90 mmHg systolic or \<50 mmHg diastolic.
• Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

QPS-MRA, LLC-Main Office

South Miami, Florida, 33143, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 16, 2020
• Study Start: March 16, 2021
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)