A Study of PF-07258669 In Healthy Adult Participants

• Status: Not yet recruiting
• Trial end date: 2022-07-20
• Target enrollment: 0
• Participant gender: All

Summary

Part A of this study is to evaluate safety, tolerability, and pharmacokinetics (PK) of PF-07258669 after administration of multiple ascending oral doses to healthy adult participants. A cohort of healthy adult Japanese participants may also be evaluated. Part B of this study is a 2-period, fixed-sequence, multiple-dose, open-label design to evaluate the effect of PF-07258669 on midazolam PK in healthy adult participants. Part B will be conducted if the results of Part A support further evaluation of PF-07258669.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Midazolam

Criteria

Inclusion Criteria:

1. Female participants of nonchildbearing potential and male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

2. 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 and to wear eye protection, as appropriate.

3. Body mass index (BMI) of 17.5 to 28.5 kg/m2; and a total body weight >50 kg (110 lb).

4. Japanese participants only: Participants enrolling as Japanese must have 4 biological Japanese grandparents who were born in Japan.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine (including thyroid), 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 defined below (eg, hypercholesterolemia, hypertriglyceridemia).

2. History of symptomatic orthostatic hypotension or symptomatic bradycardia.

3. History of eating disorders (eg, anorexia or bulimia nervosa).

4. 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.

5. Use of moderate or strong cytochrome p-450 3A (CYP3A) inhibitors or inducers within 28 days or 5 half-lives (whichever is longer) prior to first dose of study intervention.

6. 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).

7. Any lipid panel parameter except high-density lipoprotein (HDL) (ie, total cholesterol, triglycerides, and/or low-density lipoprotein (LDL)) ≥1.25× upper limit of normal (ULN).