SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02391623

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.

NCT02391623 Healthy Subjects

4 Interventions

Name: PF-06427878

Description: PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).

Type: Drug

Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5

Name: Placebo

Description: Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).

Type: Drug

Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5

Name: PF-06427878

Description: PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).

Type: Drug

Cohort 6

Name: Placebo

Description: Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).

Type: Drug

Cohort 6


Primary Outcomes

Measure: Assessment of adverse events (AEs).

Time: 0-25 days

Measure: Assessment of clinical laboratory tests.

Time: 0-25 days

Measure: Assessment of vital signs (including blood pressure and pulse rate).

Time: 0-25 days

Measure: Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

Time: 0-25 days

Secondary Outcomes

Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose

Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1

Time: 0, 1, 2, 3, 4, 6, 8, 12 hours post dose

Measure: Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1

Time: 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose

Measure: Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0- tau hours post dose

Measure: Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0- tau hours post dose

Measure: Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14

Time: 0- tau hours post dose

Purpose: Basic Science

Allocation: Randomized


There is one SNP

SNPs


1 Q12H

Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---

Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---

Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---

Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---

Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1. null. --- Q12H ---

Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12. null. --- Q12H ---

Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD. --- Q12H ---

Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---

Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14. --- Q12H ---



HPO Nodes