Testing the safety and tolerance of PF-07899895 in 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-07899895 Administered as Immediate and Modified Release Formulations in Healthy Adult Participants
This study is testing a new medicine called PF-07899895 to see if it's safe and well-tolerated in healthy adults aged 18 to 65.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région DE) |
| Trial ID | NCT06137729 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of the investigational medicine PF-07899895 in healthy adults aged 18 to 65. Participants will receive either the study medication or a placebo in a randomized manner, with multiple doses administered over a specified period. The study will monitor the participants for any adverse effects and measure the concentration of the medication in their blood after ingestion. The research will take place at the Pfizer Clinical Research Unit in Brussels.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 who meet specific health criteria and have no history of certain viral infections.
Not a fit: Patients with significant medical histories or conditions affecting drug absorption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety profile of PF-07899895, potentially leading to its future use in treating various conditions.
How similar studies have performed: Other studies evaluating the safety of new medications in healthy volunteers have shown success, making this approach a standard practice in clinical research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels, Bruxelles-capitale, Région DE
- Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région DE, Belgium (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.