Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants
Study Details
Study Description
Brief Summary
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion. This is a randomized, double-blind, sponsor-open, placebo-controlled trial. There will be 2 cohorts with a total of approximately 16 participants planned (approximately 8 participants in each cohort).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment PF-07304814 assignment |
Drug: PF-07304814
Participants will receive PF-07304814
|
| Placebo Comparator: Placebo Placebo assigned |
Drug: Placebo
Participants will recieve placebo
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment emergent treatment-related adverse event(s) [Dosing through follow-up call (28-32 days after last dose of investigational product)]
Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
- Number of participants with laboratory test findings of potential clinical importance [Dosing through Day 5 of last period]
Percentage of subjects with laboratory abnormalities
- Number of participants with vital signs findings of potential clinical importance [Dosing through Day 5 of last period]
blood pressure, pulse rate, temperature, respiration rate
- Number of participants with ECG findings of potential clinical importance [Dosing through Day 5 of last period]
Number of subjects with change from baseline in electrocardiogram (ECG) parameters
Secondary Outcome Measures
- Plasma Cmax of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Maximum plasma concentration
- Plasma C24 of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Plasma concentration at the end of infusion (24 hours post the start of infusion)
- Plasma Css of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Plasma steady state concertation
- Plasma AUClast of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.
- Plasma AUCinf of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Area under the serum concentration time profile from time zero to infinity.
- Plasma AUCinf (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Dose normalized AUCinf
- Plasma Css (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Dose normalized Css
- Plasma t1/2 of PF-07304814 (prodrug) and PF 00835231 (active moiety) [0-48 hours post the start of dosing]
Terminal half life
- Plasma CL of PF-07304814 (prodrug) [0-48 hours post the start of dosing]
Clearance
- Plasma Vdss of PF-07304814 (prodrug) [0-48 hours post the start of dosing]
Volume of distribution at steady state
- PF-00835231 urinary PK: Ae [0-36 hours post the start of dosing]
Amount of unchanged drug excreted in urine over collection interval
- PF-00835231 urinary PK: Ae% [0-36 hours post the start of dosing]
Percent of dose excreted in urine as unchanged drug over the collection interval.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female participants must be 18 to 60 years of age. All fertile participants must agree to use a highly effective method of contraception.
-
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination.
-
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent.
Exclusion Criteria
-
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
-
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
-
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
-
History of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism.
-
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
-
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).
-
A positive urine drug test at screening or admission and confirmed by repeat test, if deemed necessary.
-
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
-
Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
-
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
-
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
-
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Haven Clinical Research Unit | New Haven | Connecticut | United States | 06511 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4611007