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HealthyPhase 1NCT04323124

Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants

A Phase 1 study testing PF-07059013 in people with Healthy, run by Pfizer at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants. Additionally, effects of different formulations and food on parameters, including PK may be explored. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PF-07059013
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
1 siteBelgium
Study dates
17 Jul 2020to 21 Oct 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female (of non-child bearing potential) participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD.
  • Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure, pulse rate, respiratory rate and temperature measurement, standard 12 lead ECG, laboratory tests, and cardiac monitoring (in Part 1 only).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Weight:
  • BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception a positive HBsAb test due to hepatitis B vaccination is permissible.
  • 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 or, in the investigator's judgment, make the participant inappropriate for the study.
  • 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).
Show all 23Show fewer
  • A positive urine drug test at screening or admission.
  • A positive urine cotinine test at screening or admission in Part 1 and 2.
  • Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete left bundle branch block (LBBB), signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular (AV) block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • AST or ALT level ≥1.5 × ULN;
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN;
  • PT/INR >1.2 × ULN;
  • aPTT ≥1.5 × ULN;
  • Hemoglobin <11.0 g/dL;
  • Lactate >1 x ULN.
  • For Part 2 only, participants with absolute reticulocyte count >150,000/uL at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary.
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
  • Use of tobacco/nicotine containing products for Part 1 or 2, and use of more than 5 cigarettes/day for Part 3.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

    Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE ESCALATION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07059013 AND OPEN-LABEL ASSESSMENT OF FOOD AND FORMULATION ON PHARMACOKINETICS OF PF-07059013 IN HEALTHY ADULT PARTICIPANTS

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants. Additionally, effects of different formulations and food on parameters, including PK may be explored.

Conditions
Healthy
Being tested
PF-07059013, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07059013Drug

    Participants will recieve PF-07059013

  • PlaceboDrug

    Participants will recieve placebo

Study groups in NCT04323124
Study groupRoleWhat they receive
TreatmentExperimentalPF-07059013 assignment
Receives: Drug: PF-07059013
PlaceboPlacebo comparatorPlacebo assignment
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE)

    Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study treatment was determined by the investigator.

    Duration of participation of Part 1 and Part 3, from the screening visit to the follow-up phone call, was approximately 15 weeks. Duration of participation of Part 2, from the screening visit to the follow-up phone call, was approximately 10 weeks.

    Measured: Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2)

  2. Number of Participants With Laboratory Test Findings of Potential Clinical Importance

    Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. Laboratory test with abnormalities are reported.

    Evaluation activities as:

    Part 1: At Screening, Day -1, and Day 1 (at 8 hours post dose), 2, 5, 8. Part 2: At Screening, Day -1, 1, 2, 4, 7, 10, 14, 18, 21. Part 3: At Screening, Day -1, 2, 5.

    Measured: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.

  3. Number of Participants With Vital Signs Findings of Potential Clinical Importance

    Vital sign data included supine blood pressure, pulse rate, orthostatic blood pressure and oral temperature. Vital signs with abnormalities are reported.

    Evaluation activities as:

    Part 1: Supine blood pressure and pulse rate: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Orthostatic blood pressure, respiratory rate and oral temperature: 0, 2, 8, and 24 hours post dose.

    Part 2: Supine blood pressure and pulse rate: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Orthostatic blood pressure, respiratory rate and oral temperature: Day 1, 7, 14, 18.

    Part 3: Supine blood pressure and pulse rate: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose. Respiratory rate and oral temperature: 0, 24 and 96 hours post dose.

    Measured: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.

  4. Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance

    Clinical significance of 12-Lead ECG data was assessed by the investigator. ECG findings with abnormalities were reported.

    Evaluation activities as:

    Part 1: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose.

    Part 2: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Part 3: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose.

    Measured: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.

Secondary outcomes (8)

  1. PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1

    PF-07059013 Blood and Plasma Cmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.

    Measured: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.

  2. PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1

    PF-07059013 Blood and Plasma Tmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.

    Measured: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.

  3. PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1

    PF-07059013 Blood and Plasma AUClast of Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.

    Measured: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.

  4. PF-07059013 Blood and Plasma Cmax of Part 2

    PF-07059013 Blood and Plasma Cmax of Part 2 was evaluated.

    Measured: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.

  5. PF-07059013 Blood and Plasma Tmax of Part 2

    PF-07059013 Blood and Plasma Tmax of Part 2 was evaluated.

    Measured: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.

  6. PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2

    PF-07059013 Blood and Plasma AUCtau (the Dosing Interval, Where Tau = 24 Hours for QD Dosing) for Part 2 was evaluated.

    Measured: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.

  7. p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1

    p20 and p50 change from baseline in Part 1 was evaluated.

    Measured: Part 1: 0 and 8 hours post dose.

  8. p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2

    p20 and p50 change from baseline in Part 2 was evaluated.

    Measured: Part 2: 0 and 8 hours post dose on Day 1, 7 and 14, and on Day 2, 15, 18.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2020
  2. Study start17 Jul 2020
  3. Primary completion21 Oct 2021
  4. Study completion21 Oct 2021

Why it stopped: Study was terminated as it did not demonstrate sufficient pharmacological effect. Termination was not related to safety reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04323124
Sponsor's protocol ID
C4061001
Other IDs
2019-004918-34, 2019
Status last verified
May 2024
First submitted
18 Mar 2020
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Lee KC, Wan KX, Barricklow J, Lim CN, Clarke S, Potts D, Holmes K, Gonzalez P, Kavetska O. Using Mitra sampling to support first-in-human pharmacokinetic evaluations for PF-07059013. Bioanalysis. 2023 Sep;15(17):1083-1094. doi: 10.4155/bio-2023-0066. Epub 2023 Aug 16.

    PubMed 37584365

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07059013 in people with Healthy, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) (time frame: Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04323124, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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