Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05554237 | A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. | PHASE1 | COMPLETED | 42 | — | — | Oct 7, 2022 | Jun 23, 2023 | Oct 10, 2024 | 1 | Belgium |
AUClast was determined using the linear/log trapezoidal method.
Dose-normalized Cmax was determined as Cmax/Dose.
AUClast(dn) was determined as AUClast/Dose.
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.
AUCinf(dn) was calculated as AUCinf/Dose.
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.
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.
CL/F was calculated as Dose/AUCinf.
The lower limit of quantification for AVP was 1.0 ng/mL.
AUClast(dn) was determined as AUClast/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
The lower limit of quantification for AVP was 1.0 ng/mL.
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
AUClast was determined using the linear/log trapezoidal method. The lower limit of quantification for AVP was 1.0 ng/mL.
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.
AUCinf(dn) was calculated as AUCinf/Dose.
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.
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.
CL/F was calculated as Dose/AUCinf.
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.
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.
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).
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.
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).
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.
Dose-normalized Cmax was determined as Cmax/Dose.
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.
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.
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.
CL/F was calculated as Dose/AUCinf.
The lower limit of quantification for AVP was 1.0 ng/mL.
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.
The lower limit of quantification for AVP was 1.0 ng/mL.
Dose-normalized Cmax was determined as Cmax/Dose. The lower limit of quantification for AVP was 1.0 ng/mL.
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.
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.
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.
CL/F was calculated as Dose/AUCinf.
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.
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.
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).
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.
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).
| Arm | Type | Description |
|---|---|---|
| PF-07612577 | EXPERIMENTAL | Part-1: Dose 1, Dose 2, Dose 4, Dose 5 Part-2: Cohort 2-5 |
| Placebo | PLACEBO_COMPARATOR | Part-1: Dose 1-5 Part-2: Cohort 2-4 |
| PF-06264006 | EXPERIMENTAL | Part-1: Dose 3, Dose 5 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| PF-07612577 | DRUG | PF-07612577 |
| PF-06264006 | DRUG | PF-06264006 |
Inclusion Criteria: 1. BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb) 2. For optional Japanese cohort only: Japanese participants who have 4 Japanese biologic grandparents who were born in Japan 3. For optional Chinese cohort only: Chinese participants who were born in mainland...