Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06648671 · 4 trials · 3 indications
Camx after single dose of 25 mg PF-06648671 in period 1 and period 2
Tmax following single doses of PF-06648671 in period 1 and period 2
AUCinf following single doses of PF-06648671 in period 1 and period 2
AUClast following single doses of PF-06648671 in period 1 and period 2
t1/2 following single doses of PF-06648671 in period 1 and period 2
CL/F following single doses of PF-06648671 in period 1 and period 2
Vz/F following single doses of PF-06648671 in period 1 and period 2
AUC24 on day 1, 7 and 14 in part 1, day 1 and 14 in part 2
t1/2 post last dose on Day 14
CL/F on day 14
Vz/F on day 14
PF-06648671 CSF concentration on day 1 and day 14 (cohort 3) or day 15 (cohorts 5, 6 and 8) prior to dosing in part 1
accumulation of PF-06648671 plasma AUC24 on day 7 and day 14 relative to day 1 in part 1, AUC on day 14 relative to day 1 in part 2
PF-06648671 plasma Cmax on day 7 and 14 relative to day 1 in part 1, day 14 to day 1 in part 2
percentage of parent drug recovered in urine over 24 hours on day 14 in part 1 and part 2
Renal clearance of PF-06648671 on day 14
CSF Abeta 40 and 42 concentration on day 14 (cohort 3) or on day 15 (cohorts 5, 6 and 8) prior to dosing compared to day 1 baseline
the AUC ratio of midazolam between day 14 in period 2 vs day 1 in period 1 in optional part 3
the Cmax ratio of midazolam between day 14 in period 2 vs day 1 in period 1 in optional part 3
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurences of an AE within a category will be counted once within the category
Measurement of blood pressure and pulse rate
Measurement of standard 12-lead ECG, single or triplicate
Pre-defined criteria were established for each lab test to identify potential clinical importance
| Arm | Type | Description |
|---|---|---|
| single cohort | EXPERIMENTAL | single dose of PF-06648671 in period 1 and 14-day dose of itraconazole plus single dose of PF-06648671 in period 2 |
| PF-06648671 High dose group | EXPERIMENTAL | subjects receive a single oral dose of PF-06648671 at 300 mg |
| PF-06648671 Low dose group | EXPERIMENTAL | Subjects receive a single oral dose of PF-06648671 lower than 300 mg dose |
| Placebo group | PLACEBO_COMPARATOR | Subjects receive matching placebo |
| PF-06648671 Low dose group (2) | EXPERIMENTAL | Optional arm. Subjects receive a single oral dose of PF-06648671 at second lower dose if 300 mg dose is not repeated in cohort 2 |
| Multiple Doses PF-06648671 (Cohort1) | EXPERIMENTAL | Healthy subjects receive 14-day repeated dose once a day at 4 mg of PF-06648671 or matching placebo |
| Multiple Doses PF-06648671 (cohort 2) | EXPERIMENTAL | Healthy subject receive 14-day repeated dose once a day at 12 mg of PF-06648671 or matching placebo |
| Multiple doses PF-06648671 (cohort 3) | EXPERIMENTAL | Healthy subject receive 14-day repeated dose once a day at 40 mg of PF-06648671 or matching placebo and CSF LP is collected at baseline and steady state predose on day 1 and 14 |
| Multiple Doses PF-06648671 (cohort 4) | EXPERIMENTAL | Healthy subject receive 14-day repeated dose once a day at 40 mg of PF-06648671 or matching placebo |
| Multiple Doses PF-06648671 (cohort 5) | EXPERIMENTAL | Healthy subject receive 14-day repeated dose once a day at 100 mg of PF-06648671 or matching placebo, CSF LP is collected at baseline 72 hours prior to day 1 dosing and at steady-state on Day 15, 24 hours after last dosing on day 14 |
| Multiple Doses in Healthy Elderly (cohort 7) | EXPERIMENTAL | Healthy Elderly subjects receive 14-day repeated dose once a day at MTD PF-06648671 defined in healthy adult subjects (part 1) |
| Multiple Doses PF-06648671 (cohort 8) | EXPERIMENTAL | Healthy subjects receive 14-day repeated dose once a day at 360 mg of PF-06648671 or matching placebo, CSF LP is collected at baseline 72 hours prior to day 1 dosing and at steady-state on Day 15, 24 hours post last dose |
| Midazolam DDI (optional cohort 9) | EXPERIMENTAL | Healthy Subjects receive single dose of 2 mg midazolam in period 1 followed by 14 days PF-06648671 once a day and coadministration of PF-06648671 and midazolam 2 mg in period 2 (Optional cohort) |
| Multiple Doses PF-06648671 (cohort 6) | EXPERIMENTAL | Healthy subject receive 14-day repeated dose once a day at 200 mg of PF-06648671 or matching placebo, CSF LP is collected at baseline 72 hours prior to day 1 dosing and at steady-state on Day 25, 24 hours after last dosing on day 14 |
| Single Ascending Doses Cohort 1 | EXPERIMENTAL | subjects receive 3 active doses and one placebo |
| Single Ascending Doses Cohort 2 | EXPERIMENTAL | subjects receive 3 doses and one placebo |
| Cohort 3 | EXPERIMENTAL | optional cohort |
| Name | Type | Description |
|---|---|---|
| PF-06648671 | DRUG | Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2. |
| Itraconazole | DRUG | Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2 |
| Placebo | DRUG | Placebo which will be dosed as oral suspension, single doses to match PF-06648671 |
| Midazolam | DRUG | commercial available oral solution of 2 mg midazolam as CYP3A probe substrate for drug interaction evaluation. Midazolam will be given as single dose with and without co-administration of PF-06648671 |
Inclusion Criteria: 1. Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years at the time of screening, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including...
PF-06648671 is an investigational small molecule developed by Pfizer, Inc. (NYSE: PFE). It has been studied in Phase 1 clinical trials involving healthy adult and elderly volunteers. Its therapeutic indication has not been disclosed, and it remains in early-stage clinical development.
PF-06648671 is made and developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored all four Phase 1 trials of the compound, which were conducted in the United States and Belgium.
PF-06648671 is in Phase 1 clinical development. All four of its registered trials are Phase 1 studies, and all four have been completed. The compound is investigational and has not been approved by the FDA.
PF-06648671 has been evaluated in four completed Phase 1 trials: NCT02316756, a single ascending dose study; NCT02440100, a repeat-dose safety and pharmacokinetics study; NCT02407353, which measured effects on beta-amyloid concentrations in cerebrospinal fluid; and NCT02883114, a drug interaction study with itraconazole.
Across its four completed Phase 1 trials, PF-06648671 enrolled a total of 144 participants. Enrollment ranged from 12 subjects in the itraconazole drug interaction study (NCT02883114) to 92 subjects in the repeat-dose study in healthy adults and elderly subjects (NCT02440100).
Yes. The PF-06648671 Phase 1 program included randomized, double-blind, placebo-controlled designs. Participants were healthy volunteers aged 18 years and older, and the studies were conducted in the United States and Belgium.