Multiple Ascending Dose and DDI Study

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03031119

Enrollment

Registered

2017-01-25

Start date

2017-01-31

Completion date

2017-07-31

Last updated

2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

nonalcoholic steatohepatitis

Brief summary

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.

Interventions

DRUGPlacebo

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

DRUGPF-06835919

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

DRUGatorvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) on Day 7 of atorvastatin and 2 active metabolites	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	0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose	Part B
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Screening to Day 24	Part A
Number of Participants With Clinical Laboratory Abnormalities	Day -2 to Day 24	Part A
Change from baseline in vital signs	Day -1 to Day 24	Part A
Change from baseline in 12-lead electrocardiogram	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	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	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	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	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	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	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	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	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	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	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	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	0,0.5,1,1.5,2,3,4,6,9,12,24,36 and 48 hours post-atorvastatin dose	Part B

Secondary

Measure	Time frame	Description
Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A	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	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	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)	Screening to Day 18	Part B
Accumulation Ratio (Rac) on Day 14 Part A	0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose	—
Change from Baseline in Vital Signs	Day -2 to Day 18	Part B
Change from baseline in 12-lead electrocardiogram	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	0,0.5,1,2,4,5,6,8 and 12 hours post-dose	—
Number of Participants With Clinical Laboratory Abnormalities	Day -2 to Day 18	Part B
Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A	0,0.5,1,2,4,5,6,8 and 12 hours post-dose	—
Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A	0,0.5,1,2,4,5,6,8 and 12 hours post-dose	—
Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A	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	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	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	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	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	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	0,0.5,1,2,4,5,6,8 and 12 hours post-dose	—
Apparent Oral Clearance (CL/F) on Day 14 Part A	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	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	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	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 7 Part A	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	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	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	0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026