Completed

NCT Number: NCT03031119

Multiple Ascending Dose and DDI Study

Part A will investigate the safety, tolerability, PK and PD of PF-06835919 administered for 14 days in a multiple ascending dose design. Part B will assess the effect of PF-06835919 co-administration at low and high doses on the PK of atorvastatin in a single cohort.

Completed

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Key information

Conditions

Healthy Volunteers Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male and females (nonchildbearing potential)
18 to 55 years old
Body Mass Index 17.5 to 30.5

Exclusion criteria

Known hereditary fructose intolerance or fructose malabsorption disorder (Part A)
Statin intolerance (Part B)
Unable to consume high fructose syrup-containing beverage with each meal while in the unit (Part A)

Treatment and study plan

Placebo

Drug

Tablets administered once or twice daily, with food, in Part A.

PF-06835919

Drug

Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.

atorvastatin

Drug

In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.

Primary outcomes

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame: Screening to Day 24

Part A
Number of Participants With Clinical Laboratory Abnormalities

Time frame: Day -2 to Day 24

Part A
Change from baseline in vital signs

Time frame: Day -1 to Day 24

Part A
Change from baseline in 12-lead electrocardiogram

Time frame: Day -1 to Day 24

Part A
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day -1 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 3 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 7 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day -1 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 3 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 7 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 3 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Maximum Observed Plasma Concentration (Cmax) on Day -1 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Maximum Observed Plasma Concentration (Cmax) on Day 3 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Maximum Observed Plasma Concentration (Cmax) on Day 7 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Plasma Decay Half-Life (t1/2) on Day -1 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Plasma Decay Half-Life (t1/2) on Day 3 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B
Plasma Decay Half-Life (t1/2) on Day 7 of atorvastatin and 2 active metabolites

Time frame: 0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose

Part B

Secondary outcomes

Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48, and 72 hours post-dose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Apparent Oral Clearance (CL/F) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Apparent Oral Clearance (CL/F) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Minimum Observed Plasma Trough Concentration (Cmin) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Minimum Observed Plasma Trough Concentration (Cmin) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Accumulation Ratio (Rac) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Accumulation Ratio (Rac) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Plasma Decay Half-Life (t1/2) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Apparent Volume of Distribution (Vz/F) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Percent Cumulative Amount of Drug Recovered Unchanged in Urine (Ae%) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Renal Clearance (CLr) on Day 14 Part A

Time frame: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Time frame: Screening to Day 18

Part B
Number of Participants With Clinical Laboratory Abnormalities

Time frame: Day -2 to Day 18

Part B
Change from Baseline in Vital Signs

Time frame: Day -2 to Day 18

Part B
Change from baseline in 12-lead electrocardiogram

Time frame: Day -2 to Day 18

Part B
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 7 Part A

Time frame: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Multiple Oral Doses Of Pf-06835919 In Healthy Adult Subjects (Part A); And An Open-label Study To Assess Multiple Oral Doses Of Pf-06835919 On Atorvastatin Pharmacokinetics (Part B)

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 25, 2017
Registry last updated: Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Pfizer Clinical Research Unit

Who can participate

Treatment and study plan

Placebo

PF-06835919

atorvastatin

Primary outcomes

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Number of Participants With Clinical Laboratory Abnormalities

Change from baseline in vital signs

Change from baseline in 12-lead electrocardiogram

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day -1 of atorvastatin and 2 active metabolites

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 3 of atorvastatin and 2 active metabolites

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 7 of atorvastatin and 2 active metabolites

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day -1 of atorvastatin and 2 active metabolites

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 3 of atorvastatin and 2 active metabolites

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) on Day 7 of atorvastatin and 2 active metabolites

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 3 of atorvastatin and 2 active metabolites

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 of atorvastatin and 2 active metabolites

Maximum Observed Plasma Concentration (Cmax) on Day -1 of atorvastatin and 2 active metabolites

Maximum Observed Plasma Concentration (Cmax) on Day 3 of atorvastatin and 2 active metabolites

Maximum Observed Plasma Concentration (Cmax) on Day 7 of atorvastatin and 2 active metabolites

Plasma Decay Half-Life (t1/2) on Day -1 of atorvastatin and 2 active metabolites

Plasma Decay Half-Life (t1/2) on Day 3 of atorvastatin and 2 active metabolites

Plasma Decay Half-Life (t1/2) on Day 7 of atorvastatin and 2 active metabolites

Secondary outcomes

Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A

Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A

Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A

Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 Part A

Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 14 Part A

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 Part A

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 Part A

Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14 Part A

Apparent Oral Clearance (CL/F) on Day 7 Part A

Apparent Oral Clearance (CL/F) on Day 14 Part A

Minimum Observed Plasma Trough Concentration (Cmin) on Day 7 Part A

Minimum Observed Plasma Trough Concentration (Cmin) on Day 14 Part A

Accumulation Ratio (Rac) on Day 7 Part A

Accumulation Ratio (Rac) on Day 14 Part A

Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 7 Part A

Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 14 Part A

Plasma Decay Half-Life (t1/2) on Day 14 Part A

Apparent Volume of Distribution (Vz/F) on Day 14 Part A

Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A

Percent Cumulative Amount of Drug Recovered Unchanged in Urine (Ae%) on Day 14 Part A

Renal Clearance (CLr) on Day 14 Part A

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

Number of Participants With Clinical Laboratory Abnormalities

Change from Baseline in Vital Signs

Change from baseline in 12-lead electrocardiogram

Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 7 Part A

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

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