Healthy AdultsPhase 1NCT05093205

STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS

A Phase 1 study testing PF-06882961, Atorvastatin and Midazolam in people with Healthy Adults, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to characterize the effect of PF-06882961, administered at 2 steady-state dose levels, on the PK of single doses of atorvastatin (20 mg) or midazolam (5 mg), administered separately, in healthy adult male and female participants (Part A), or an OC in healthy PM female participants (Part B). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adults
What is being tested?: PF-06882961, Atorvastatin and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 25 Oct 2021to 6 Jul 2022
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Part A Only - Healthy male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12 lead ECG and clinical laboratory tests).
Part B Only - Healthy PM female participants between 40 and 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including BP and PR measurement, standard 12 lead ECG and clinical laboratory tests). Subjects must be amenorrheic for at least 12 months. Women who are 60 years of age or younger must also have an FSH that is within the laboratory's reference range for PM women.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI- 20.0 kg/m2 to <30.0 kg/m2 at Screening.
Stable body weight, defined as <5 % change (per participant report) for 90 days before Screening.
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, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
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.
Known intolerance or hypersensitivity to GLP-1R agonists.
Known hypersensitivity to atorvastatin or midazolam (for participants in Part A), or LE and EE (for participants in Part B).
Personal or family history of MTC or MEN2 or study participants with suspected MTC per the investigator's judgment.

Show all 40Show fewer

Symptomatic gallbladder disease.
History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years from screening.
Any lifetime history of a suicide attempt.
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.
Systemic therapy with any of the medications that are moderate or strong CYP3A4/5, CYP2C9 and/or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer) or moderate or strong CYP3A, CYP2C9 and/or CYP2C19 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
Systemic therapy with inhibitors of the BCRP transporter within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s).
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).
Known prior participation in a trial involving PF-06882961.
A PHQ-9 score ≥15 obtained at Screening or Day -1 in Study.
Response of "yes" to question 4 or 5, or on any suicidal behavioral question on the C SSRS at Screening or Day -1 in Study.
A positive urine drug test.
Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. BP should be measured in triplicate and the average of the 3 BP values should be used to determine the participant's eligibility. Note: At screening, the participant's arm circumference should be measured (eg, using a flexible anthropometric tape) at the midpoint of the length of the upper arm and the appropriate cuff selected and used throughout the study.
Screening 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF 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:
HbA1c ≥6.5%.
Aspartate AST or ALT level ≥2 times the ULN.
Total bilirubin level ≥1.5 times the 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.
TSH >1.5x the ULN or <LLN.
Serum calcitonin > the ULN.
Amylase or lipase > the ULN.
Fasting blood glucose ≥126 mg/dL.
Fasting C-peptide <0.8 ng/mL.
eGFR <70 mL/min/1.73 m2 as calculated by the CKD-EPI equation.
Positive testing for HIV, HepBsAg, or HCVAb. Study participants positive for HCVAb are to be excluded unless known to have been treated with a known curative therapy and negative for HCV RNA. Hepatitis B vaccination is allowed.
A positive SARS-CoV-2 test.
Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.
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).
Current use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
Known or suspected illicit drug use.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing randomization (Day-1).
History of sensitivity to heparin or heparin induced thrombocytopenia if Hep-lock is used for IV blood draw.
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.

United States1 site

Anaheim Clinical Trials, LLC
Anaheim, California, 92801

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, TWO-PART STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ATORVASTATIN AND MIDAZOLAM IN HEALTHY ADULTS AND AN ORAL CONTRACEPTIVE IN HEALTHY POST-MENOPAUSAL FEMALES

Conditions: Healthy Adults
Being tested: PF-06882961, Atorvastatin, Midazolam, Levonorgestrel & Ethinyl Estradiol

What participants receive

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

PF-06882961Drug
Tablets
AtorvastatinDrug
Tablets
MidazolamDrug
Syrup
Levonorgestrel & Ethinyl EstradiolDrug
Tablet

Study groups in NCT05093205
Study group	Role	What they receive
Part A	Experimental	To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of atorvastatin (20 mg tablet) and midazolam (5 mg syrup). Receives: Drug: PF-06882961; Drug: Atorvastatin; Drug: Midazolam
Part B	Experimental	To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of an Oral Contraceptive (Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg tablet). Receives: Drug: PF-06882961; Drug: Levonorgestrel & Ethinyl Estradiol

What is being measured

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

(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7
Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8
Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5
Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Measured: For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.

Secondary outcomes (14)

(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.
(Part B) Number of Participants With TEAE During Part B of the Study
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.
(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)
Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.
Measured: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)
Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.
Measured: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine blood pressure (mm Hg) and pulse rate (beats per minute) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.
Measured: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine blood pressure (mm Hg) and pulse rate (bpm) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.
Measured: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Percentage of Change From Baseline in Body Weight
Percentage of changes from Baseline in body weight of the participants were measured.
Measured: Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.
(Part B) Percentage of Change From Baseline in Body Weight
Percentage of changes from Baseline in body weight of the participants were measured.
Measured: Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Measured: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Measured: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Measured: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
(Part B) Number of Participants With Categorical Scores on the C-SSRS
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Measured: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 [not at all] to 3 [nearly every day]. Higher score=greater severity).
Measured: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
(Part B) Number of Participants With Categorical Scores on the PHQ-9
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 [not at all] to 3 [nearly every day]. Higher score=greater severity).
Measured: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.

Timeline

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

25 Oct 20216 Jul 2022

First posted26 Oct 2021
Study start25 Oct 2021
Primary completion6 Jul 2022
Study completion6 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy AdultsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05093205
Sponsor's protocol ID: C3421047
Status last verified: Mar 2024
First submitted: 13 Oct 2021
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, TWO-PART STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ATORVASTATIN AND MIDAZOLAM IN HEALTHY ADULTS AND AN ORAL CONTRACEPTIVE IN HEALTHY POST-MENOPAUSAL FEMALES
ClinicalTrials.gov ID: NCT05093205
Acronym / sponsor ID: C3421047
Conditions: Healthy Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 25 Oct 2021 (actual)
Primary completion: 6 Jul 2022 (actual)
Study completion: 6 Jul 2022 (actual)
First posted: 26 Oct 2021 (actual)
Results: Posted 19 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Part A	Experimental	Drug: PF-06882961, Drug: Atorvastatin, Drug: MidazolamTo evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of atorvastatin (20 mg tablet) and midazolam (5 mg syrup).
Part B	Experimental	Drug: PF-06882961, Drug: Levonorgestrel & Ethinyl EstradiolTo evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of an Oral Contraceptive (Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg tablet).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Part A Only - Healthy male and female participants must be 18 to 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12 lead ECG and clinical laboratory tests).
Part B Only - Healthy PM female participants between 40 and 65 years of age, inclusive, at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including BP and PR measurement, standard 12 lead ECG and clinical laboratory tests). Subjects must be amenorrheic for at least 12 months. Women who are 60 years of age or younger must also have an FSH that is within the laboratory's reference range for PM women.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI- 20.0 kg/m2 to <30.0 kg/m2 at Screening.
Stable body weight, defined as <5 % change (per participant report) for 90 days before Screening.

Key exclusion criteria (40 listed)

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, prior bariatric surgery, gastrectomy, or any area of intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
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.
Known intolerance or hypersensitivity to GLP-1R agonists.
Known hypersensitivity to atorvastatin or midazolam (for participants in Part A), or LE and EE (for participants in Part B).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06882961Tablets	Drug	Part A, Part B
AtorvastatinTablets	Drug	Part A
MidazolamSyrup	Drug	Part A
Levonorgestrel & Ethinyl EstradiolTablet	Drug	Part B

Primary outcome

(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7
Time frame: For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8
Time frame: For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.
Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
Time frame: For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.
Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5
Time frame: For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.
Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.

14 secondary outcomes

(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Time frame: From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.
(Part B) Number of Participants With TEAE During Part B of the Study
Time frame: From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.
(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)
Time frame: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)
Time frame: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Time frame: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Time frame: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Percentage of Change From Baseline in Body Weight
Time frame: Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.
(Part B) Percentage of Change From Baseline in Body Weight
Time frame: Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
Time frame: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
Time frame: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Time frame: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Time frame: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Time frame: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.

Results and safety

Results posted to the registry on 19 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin 20 mg (Part A Period 1)	18	18
Midazolam 5 mg (Part A Period 2)	0	0
PF-06882961 Titration up to 120 mg BID (Part A Period 3)	0	0
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)	0	0
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)	0	0
PF-06882961 Titration up to 200 mg BID (Part A Period 6)	0	0
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)	0	0
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)	0	0
0.15 mg LE & 0.03 mg EE (Part B Period 1)	0	0
PF-06882961 Titration up to 120 mg BID (Part B Period 2)	0	0
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	0	0
PF-06882961 Titration up to 200 mg BID (Part B Period 4)	0	0
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)	0	0

Primary outcome: (Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7

Time frame: For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour/milliliter (ng*hr/mL)

Measure	Atorvastatin 20 mg (Part A Period 1) n = 16	PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4) n = 11	PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7) n = 3
Value	32.27 (41)	46.94 (72)	54.43 (22)

Population analysed: Only participants with evaluable results for the pharmacokinetic (PK) parameter were included in the analysis.

Primary outcome: (Part A) AUCinf of Midazolam in Periods 2, 5, and 8

Time frame: For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Midazolam 5 mg (Part A Period 2) n = 18	PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5) n = 13	PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8) n = 5
Value	70.53 (32)	58.81 (40)	49.78 (22)

Population analysed: Only participants with evaluable results for the PK parameter were included in the analysis.

Primary outcome: (Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5

Time frame: For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.. Geometric mean (Geometric Coefficient of Variation). Unit: picogram*hour/milliliter (pg*hr/mL)

Measure	0.15 mg LE & 0.03 mg EE (Part B Period 1) n = 15	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) n = 12	PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) n = 8
Value	48800 (42)	62330 (61)	66490 (57)

0.15 mg LE & 0.03 mg EE (Part B Period 1) vs PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3): Specified in comments: 122.48 (90% CI 106.96 to 140.25), Mixed Models Analysis
0.15 mg LE & 0.03 mg EE (Part B Period 1) vs PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5): Specified in comments: 143.83 (90% CI 122.64 to 168.68), Mixed Models Analysis

Population analysed: Only participants with evaluable results for the PK parameter were included in the analysis.

Primary outcome: (Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5

Time frame: For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.. Geometric mean (Geometric Coefficient of Variation). Unit: pg*hr/mL

Measure	0.15 mg LE & 0.03 mg EE (Part B Period 1) n = 16	PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3) n = 12	PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5) n = 9
Value	772.1 (41)	723.5 (24)	604.4 (33)

0.15 mg LE & 0.03 mg EE (Part B Period 1) vs PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3): Specified in comments: 104.46 (90% CI 92.56 to 117.89), Mixed Models Analysis
0.15 mg LE & 0.03 mg EE (Part B Period 1) vs PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5): Specified in comments: 92.77 (90% CI 81.05 to 106.19), Mixed Models Analysis

Population analysed: Only participants with evaluable results for the PK parameter were included in the analysis.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin 20 mg (Part A Period 1)	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Midazolam 5 mg (Part A Period 2)	0 of 18 (0%)	3 of 18 (16.7%)	0 of 18
PF-06882961 Titration up to 120 mg BID (Part A Period 3)	0 of 17 (0%)	13 of 17 (76.5%)	0 of 17
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)	0 of 13 (0%)	5 of 13 (38.5%)	0 of 13
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
PF-06882961 Titration up to 200 mg BID (Part A Period 6)	0 of 13 (0%)	12 of 13 (92.3%)	0 of 13
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
0.15 mg LE & 0.03 mg EE (Part B Period 1)	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
PF-06882961 Titration up to 120 mg BID (Part B Period 2)	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)	0 of 14 (0%)	7 of 14 (50%)	0 of 14
PF-06882961 Titration up to 200 mg BID (Part B Period 4)	0 of 12 (0%)	12 of 12 (100%)	0 of 12
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

Limitations and caveats (from the sponsor): In part A, a majority of participants discontinued from study interventions due to SARS-CoV-2 infection and data from only 3 to 4 participants were evaluable following administration of danuglipron 200 mg BID. The resulting data should, therefore, be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06882961, Atorvastatin and Midazolam in people with Healthy Adults, run by Pfizer at 1 site in United States.

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 40 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: finished, as of the sponsor's last update on 19 Aug 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 United States. 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. 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 Aug 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?

(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7 (time frame: For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.). 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 NCT05093205.

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 Aug 2024.