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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004649-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Tablets administered once or twice daily, with food, in Part A for 14 days. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets administered once or twice daily, with food, in Part A. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000730020 | PF-06835919 |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
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 |
| 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 (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 |
| 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 |
| 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) | Part B | Screening to Day 18 |
| Number of Participants With Clinical Laboratory Abnormalities | Part B | Day -2 to Day 18 |
| Change from Baseline in Vital Signs | Part B | Day -2 to Day 18 |
| Change from baseline in 12-lead electrocardiogram | Part B | Day -2 to Day 18 |
| 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 |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |