A Study to Learn How the Study Medicine PF-07899895 Are Tolerated and Act in the Body of Healthy Adults

Launched by PFIZER · Nov 14, 2023

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ClinConnect Summary

This clinical trial is studying a medicine called PF-07899895 to see how safe it is and how it behaves in the body of healthy adults. The researchers want to find out the best doses of this medicine and how much stays in the blood after taking it. They are looking for men and women aged 18 to 65 who are in good health and do not have certain viral infections like HIV or hepatitis.

Participants in the study will be randomly assigned to receive either PF-07899895 or a placebo (a dummy pill that doesn’t contain any medicine). The trial has two parts: in the first part, participants will take up to five doses of the medicine or placebo and stay at the clinic for a few days after each dose for monitoring. In the second part, they will take the medicine for ten days and will stay in the clinic for additional checks. Overall, participation in the study could last between 11 to 18 weeks, and participants will have blood samples taken several times during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants, male or female, must be 18 to 65 years of age, inclusive, at the time of signing the ICD.
• • BMI of 16 to 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, vital signs assessments, oral temperature, 12-lead ECGs, and laboratory tests.
• Exclusion Criteria:
• • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
• • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, bowel resection) or gastrointestinal (GI) transit time (eg, constipation).
• • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb); positive or indeterminate QuantiFERON test for tuberculosis. Hepatitis B vaccination is allowed.
• • 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.
• • History of undesired reactions to the sun (photosensitivity).
• • Recent exposure to live or attenuated vaccines within 28 days of the screening visit.
• • 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, with the exception of moderate or strong cytochrome P450 3A (CYP3A) inducers or inhibitors which are prohibited within 14 days plus 5 half-lives prior to the first dose of study intervention.
• • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of PF-07899895 used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.