Understanding how PF-06414300 affects healthy adults

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO CONTROLLED STUDY TO ASSESS SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING ORAL DOSES OF PF-06414300 ADMINISTERED AS IMMEDIATE AND MODIFIED RELEASE FORMULATIONS IN HEALTHY ADULT PARTICIPANTS

This study tests how different doses of the medication PF-06414300 affect healthy adults to see how their bodies handle it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Pfizer (Industry-sponsored)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06659250 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the effects of different doses and forms of the medication PF-06414300 in healthy adult participants. It involves administering either the study medication or a placebo in a controlled manner, with participants monitored closely for several days after each dose. The study is divided into two parts, with participants receiving a total of 14 doses over the course of the trial. Blood samples will be taken to measure how the medication is processed and eliminated by the body.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a body mass index between 16 and 32 kg/m².

Not a fit: Patients with significant medical histories or conditions that could affect their health or the study outcomes may not benefit from participation.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of PF-06414300, informing future treatments.

How similar studies have performed: Other studies involving pharmacokinetic assessments of new medications in healthy adults have shown success, making this approach well-established.

Eligibility criteria

Inclusion Criteria:

* Body mass Index (BMI) of 16-32 kg/m2; and a total body weight \>50 kg (110 lb).
* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs assessments, 12-lead ECGs and laboratory tests.
* Additional criterion for participants to be enrolled in the Japanese cohort only: Participants who have 4 Japanese biologic grandparents born in Japan; body weight \>45 kg (99 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension irrespective of age), hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 1 week prior to first dose.
* Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.

Where this trial is running

New Haven, Connecticut

• Pfizer Clinical Research Unit - New Haven — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Pfizer CT.gov Call Center

Conditions Healthy Participants; Healthy adults; First in human