A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.

NCT05554237 | Completed Phase 1 Results DMC

• 2 other identifiers: C46910012021-005428-39
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants. CTB+AVP is a study medicine that is being developed to treat people with complicated urinary tract infections. This study is seeking healthy adult male and female participants, 18-60 years of age, with a body weight \> 50 kg and a BMI of 17.5 to 30.5 kg/m2. Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP. Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day for 7 days. The study team will monitor how each participant is doing with the study treatments via close monitoring in an in-patient setting. Experiences of people receiving CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP is safe and well-tolerated at each dose of the study medicine. Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of the study, blood samples for study medicine levels, and various measures for monitoring safety such as blood samples for clinical laboratory measurements, electrocardiograms and vital sign measurements will be taken.

Conditions

Healthy

Outcome Measures

Primary Outcomes (46)

• Maximum Observed Concentration (Cmax) of Cis-Ceftibuten (CTB): Part 1

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Time for Cmax (Tmax) of CTB: Part 1

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of CTB: Part 1

  AUClast was determined using the linear/log trapezoidal method.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized Cmax (Cmax[dn]) of CTB: Part 1

  Dose-normalized Cmax was determined as Cmax/Dose.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized AUClast (AUClast[dn]) of CTB: Part 1

  AUClast(dn) was determined as AUClast/Dose.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of CTB: Part 1

  AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized AUCinf (AUCinf[dn]) of CTB: Part 1

  AUCinf(dn) was calculated as AUCinf/Dose.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Terminal Half-Life (t1/2) of CTB: Part 1

  T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Apparent Volume of Distribution (Vz/F) of CTB: Part 1

  Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Apparent Clearance (CL/F) of CTB: Part 1

  CL/F was calculated as Dose/AUCinf.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Maximum Observed Concentration (Cmax) of AVP, Avibactam (AVI) and Hydroxy Pivalic Acid (HPA): Part 1

  The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized AUClast (AUClast[dn]) of AVP, AVI and HPA: Part 1

  AUClast(dn) was determined as AUClast/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Time for Cmax (Tmax) of AVP, AVI and HPA: Part 1

  The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 1

  Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Area Under the Plasma Concentration Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AVP, AVI and HPA: Part 1

  AUClast was determined using the linear/log trapezoidal method. The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of AVP, AVI and HPA: Part 1

  AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Dose-Normalized AUCinf (AUCinf[dn]) of AVP, AVI and HPA: Part 1

  AUCinf(dn) was calculated as AUCinf/Dose.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Terminal Half-Life (t1/2) of AVP, AVI and HPA: Part 1

  T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA : Part 1

  Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 1

  CL/F was calculated as Dose/AUCinf.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,14 and 24 hours post dose

• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Severe TEAEs and Related TEAEs: Part 1

  An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual activities of daily life (ADL), or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.

  From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)

• Number of Participants With Withdrawals Due to TEAEs: Part 1

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.

  From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 52 days)

• Number of Participants With Laboratory Test Abnormalities: Part 1

  The laboratory abnormalities with non-zero participants were reported and it included: monocytes or leukocytes (greater than \[\>\] 1.2\* upper limit of normal \[ULN\]), urine hemoglobin scalar (greater than or equal to \[\>=1\]) and leukocyte esterase scalar (\>=1).

  Up to 24 hours post-dose

• Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 1

  Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.

  Up to 24 hours post-dose

• Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 1

  Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond \[msec\], maximum \[max.\] \>=300; baseline \> 200 and max. increase \>= 25 percent (%); baseline \> 200 and max. increase \>= 25%), QRS duration aggregate (msec, max \>=140; max. increase \>= 50%), QT interval aggregate (msec, value \> 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 \< max \<= 480; 480 \< max. \<= 500; max. \> 500; 30 \< max. increase \<= 60; max. increase \> 60).

  Up to 24 hours post-dose

• Maximum Observed Concentration (Cmax) of Cis-CTB and Trans-CTB: Part 2

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Time for Cmax (Tmax) of Cis-CTB and Trans-CTB: Part 2

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of Cis-CTB and Trans-CTB: Part 2

  Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7

• Dose-Normalized Cmax (Cmax[dn]) of Cis-CTB and Trans-CTB : Part 2

  Dose-normalized Cmax was determined as Cmax/Dose.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Dose-Normalized AUCtau (AUCtau[dn]) of Cis-CTB and Trans-CTB: Part 2

  Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Terminal Half-Life (t1/2) of Cis-CTB and Trans-CTB on Day 7: Part 2

  T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Apparent Volume of Distribution (Vz/F) of Cis-CTB and Trans-CTB : Part 2

  Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Apparent Clearance (CL/F) of Cis-CTB and Trans-CTB: Part 2

  CL/F was calculated as Dose/AUCinf.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Maximum Observed Concentration (Cmax) of AVP, AVI and HPA: Part 2

  The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Area Under the Plasma Concentration Time Curve From Time Zero to Time Tau, the Dosing Interval (AUCtau) of AVP, AVI and HPA: Part 2

  Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7

• Time for Cmax (Tmax) of AVP, AVI and HPA: Part 2

  The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Dose-Normalized Cmax (Cmax[dn]) of AVP, AVI and HPA: Part 2

  Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Dose-Normalized AUCtau (AUCtau[dn]) of AVP, AVI and HPA: Part 2

  Area under the plasma concentration time profile from time zero to time tau, the dosing interval, where tau is equal to 8 hours for three times daily (TID) dosing.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Terminal Half-Life (t1/2) of AVP, AVI and HPA on Day 7: Part 2

  T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for HPA was 10.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on day 7

• Apparent Volume of Distribution (Vz/F) of AVP, AVI and HPA: Part 2

  Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The lower limit of quantification for AVI and HPA was 10.0 ng/mL.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Apparent Clearance (CL/F) of AVP, AVI and HPA: Part 2

  CL/F was calculated as Dose/AUCinf.

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

• Number of Participants With TEAEs, Severe TEAEs and Related TEAEs: Part 2

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were are any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. Severe TEAEs were defined as type of AE that interrupted usual ADL, or significantly affects clinical status, or may require intensive therapeutic intervention. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study intervention.

  From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)

• Number of Participants With Withdrawals Due to TEAEs: Part 2

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention.

  From start of treatment up to 28 to 35 days post last dose of study intervention (approximately 42 days)

• Number of Participants With Laboratory Test Abnormalities: Part 2

  The laboratory abnormalities with non-zero participants were reported and it included: neutrophils/ leukocytes (less than \[\<\] 0.8x lower limit of normal \[LLN\]), eosinophils/leukocytes (\>1.2x ULN), monocytes/leukocytes (\>1.2x ULN), bicarbonate (\>1.1x ULN), urine glucose (\>=1), ketones scalar (\>=1), urine hemoglobin scalar (\>=1), leukocyte esterase scalar (\>=1).

  From start of treatment up to Day 7

• Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: Part 2

  Vital signs included blood pressure and pulse rate and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinically significant changes in vital signs were determined by the investigator.

  From start of treatment up to Day 7

• Number of Participants With Electrocardiogram (ECG) Abnormalities: Part 2

  Twelve lead ECGs were collected using an ECG machine that automatically calculated heart rate and measured PR interval, QRS duration, QT interval, QT interval correct by Bazzette's formula (QTcB) and QT interval correct by Frederica formula QTcF. ECG abnormalities included: PR interval aggregate (millisecond \[msec\], maximum \[max.\] \>=300; baseline \> 200 and max. increase \>= 25 percent (%); baseline \> 200 and max. increase \>= 25%), QRS duration aggregate (msec, max \>=140; max. increase \>= 50%), QT interval aggregate (msec, value \> 500), QTCB interval aggregate and QTCF interval aggregate (msec, 450 \< max \<= 480; 480 \< max. \<= 500; max. \> 500; 30 \< max. increase \<= 60; max. increase \> 60).

  From start of treatment up to Day 7

Secondary Outcomes (11)

• Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2

  anytime between 0 to 8 hours post dose on Day 6

• Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of Cis-CTB, Trans-CTB, AVP, AVI and HPA: Part 2

  anytime between 0 to 8 hours post dose on Day 6

• Renal Clearance (CLr) of Cis-CTB, Trans-CTBa, AVP, AVI and HPA: Part 2

  anytime between 0 to 8 hours post dose on Day 6

• Maximum Observed Concentration (Cmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 7

• Time for Cmax (Tmax) of Cis-CTB, AVP, AVI and HPA in Japanese and Chinese Cohorts: Part 2

  pre-dose,0.5,1,1.5,2,2.5,3,4,6 and 8 hours post dose on Day 1 and 6; pre-dose,0.5,1,1.5,2,2.5,3,4,6,8,12,16 and 24 hours post dose on Day 7

Study Arms (3)

PF-07612577

EXPERIMENTAL

Part-1: Dose 1, Dose 2, Dose 4, Dose 5 Part-2: Cohort 2-5

Drug: PF-07612577

Placebo

PLACEBO COMPARATOR

Part-1: Dose 1-5 Part-2: Cohort 2-4

Drug: Placebo

PF-06264006

EXPERIMENTAL

Part-1: Dose 3, Dose 5

Drug: PF-06264006

Interventions

Placebo DRUG

Placebo

Also known as: Placebo comparator

Placebo

PF-07612577 DRUG

PF-07612577

Also known as: CTB+AVP

PF-07612577

PF-06264006 DRUG

PF-06264006

Also known as: ceftibuten (CTB)

PF-06264006

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
• For optional Japanese cohort only: Japanese participants who have 4 Japanese biologic grandparents who were born in Japan
• For optional Chinese cohort only: Chinese participants who were born in mainland China, and both parents are of Chinese descent.

You may not qualify if:

• 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)
• Known allergy to the cephalosporin group of antibiotics
• 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 \[or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence)\] that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
• A positive urine drug test
• Positive test result for SARS-CoV-2 infection at the time of screening or Day -1

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

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

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Ceftibuten

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant and investigator-blinded and sponsor-open design for Part-1 and Part-2.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: October 7, 2022
• Primary Completion: June 23, 2023
• Study Completion: June 23, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)