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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06137729
• Other study ID #: C5471001
• Secondary ID: 2023-507354-32-0
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 17, 2023
• Est. completion date: August 2, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of the study are as follows: - To understand how safe and tolerable different amounts of study medicine (PF-07899895) are. - To measure the amount of PF-07899895 in blood after the medicine is taken by mouth. The study is seeking participants who: - Are male or female of 18 to 65 years of age. - Are in good health condition. - Have not had viral infections (HIV, HBV, or HCV). HIV, human immunodeficiency virus. HBV, hepatitis B virus. HCV, hepatitis C virus. - Have tested negative for tuberculosis. Participants will receive either PF-07899895 or placebo (dummy pill) by chance. In the first part of the study (Part A): - Each participant will receive a total of up to 5 doses of the medicine or placebo with at least 5 days between each dose. - After each dose, participants will stay in study clinic for 3 to 5 days. In the second part of the study (Part B): - Each participant will need to take 10 days of dosing and will stay in the study clinic for clinical checks for 13 days. The planned duration of participation from screening to follow-up in: - Part A of the study is up to 15 to 18 weeks. - Part B of the study is up to 11 weeks. Participants will also have their blood collected by the study doctors several times.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: August 2, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-07899895
Participants will receive oral ascending doses.
• Placebo
Participants will receive matching placebo.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs following single and multiple ascending doses		Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B)
Primary	Number of subjects with laboratory abnormalities		Day 1 up to Day 7 (Part A)/Day 1 up to Day 17 (Part B)
Primary	Number of subjects with change from baseline in vital signs		Day 1 up to Day 7 (Part A)/Day 1 up to Day 17 (Part B)
Primary	Number of subjects with change from baseline in electrocardiogram (ECG) parameters		Day 1 up to Day 7 (Part A)/Day 1 up to Day 17 (Part B)
Primary	Number of subjects with change from baseline in physical examinations (PE)		Day 1 up to Day 7 (Part A)/Day 1 up to Day 17 (Part B)
Secondary	Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)		Day 1 up to Day 3 (Part A)
Secondary	Dose normalized AUClast divided by dose (AUClast(dn))		Day 1 up to Day 3 (Part A)
Secondary	Maximum Observed Plasma Concentration (Cmax)		Day 1 (Part A)/Day 1 and Day 10 (Part B)
Secondary	Dose normalized Cmax divided by dose (Cmax(dn))		Day 1 (Part A)/Day 1 and Day 10 (Part B)
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		Day 1 (Part A)/Day 1 and Day 10 (Part B)
Secondary	Area under the concentration time-profile from time 0 extrapolated to infinity (AUCinf)		Day 1 up to Day 3 (Part A)
Secondary	Dose normalized AUCinf divided by dose (AUCinf(dn))		Day 1 up to Day 3 (Part A)
Secondary	Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half (t½)		Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B)
Secondary	Apparent clearance (CL/F)		Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B)
Secondary	Apparent volume of distribution after oral dose is influenced by the fraction absorbed (Vz/F)		Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B)
Secondary	Area under the concentration-time curve from time 0 to time tau, where tau=24 hrs (AUCtau)		Day 1 and Day 12 (Part B)
Secondary	Dose normalized AUCtau divided by dose (AUCtau(dn))		Day 1 and Day 12 (Part B)
Secondary	Observed accumulation ratio for AUCtau (Rac)		Day 1 and Day 12 (Part B)
Secondary	Observed accumulation ratio for Cmax (Rac,Cmax)		Day 1 and Day 12 (Part B)

External Links

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