Multiple Ascending Dose and DDI Study

NCT03031119 | Completed Phase 1

• 2 other identifiers: C10610022016-004649-10
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

nonalcoholic steatohepatitis

Outcome Measures

Primary Outcomes (18)

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

  Part A

  Screening to Day 24

• Number of Participants With Clinical Laboratory Abnormalities

  Part A

  Day -2 to Day 24

• Change from baseline in vital signs

  Part A

  Day -1 to Day 24

• Change from baseline in 12-lead electrocardiogram

  Part A

  Day -1 to Day 24

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

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

  Part B

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

Secondary Outcomes (26)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Tablets administered once or twice daily, with food, in Part A for 14 days.

Drug: Placebo

PF-06835919

EXPERIMENTAL

Tablets administered once or twice daily, with food, in Part A for 14 days. Tablets administered once or twice daily, for 4 days at a low dose and for 4 days at a higher dose, with food and atorvastatin in Part B.

Drug: PF-06835919; Drug: atorvastatin

atorvastatin

EXPERIMENTAL

In Part B, tablets administered once or twice daily, with food, with and without a low dose of PF-06835919 for 4 days and a higher dose of PF-06835919 for 4 days.

Drug: PF-06835919; Drug: atorvastatin

Interventions

Placebo DRUG

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

Placebo

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.

PF-06835919; atorvastatin

atorvastatin DRUG

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

PF-06835919; atorvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

PF-06835919; Atorvastatin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)