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)
| Registry | NCT03031119 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: double, basic science |
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| Enrollment | 62 (Actual) |
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| Sponsor | Pfizer (Industry) |
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| Conditions | Healthy Volunteers |
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| Interventions | Placebo, PF-06835919, atorvastatin (Drug) |
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| Dates | start 2017-01-01, primary completion 2017-07-01, completion 2017-07-01, first posted 2017-01-25, last updated 2017-09-06 |
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| Locations | 1 site in Belgium |
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Related Papers Related Patents Related Grants Related Experts
All trials for Healthy Volunteers All trials of Placebo All trials of PF-06835919
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Placebo | Placebo comparator | Drug: Placebo | Tablets administered once or twice daily, with food, in Part A for 14 days. |
| PF-06835919 | Experimental | Drug: PF-06835919; Drug: atorvastatin | 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 | Drug: PF-06835919; Drug: atorvastatin | 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. |
- 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.
+Outcome measures
Primary outcomes
- 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 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
- 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 outcomes
- 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 (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) [Screening to Day 18]: Part B
- Number of Participants With Clinical Laboratory Abnormalities [Day -2 to Day 18]: Part B
- 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]
+Eligibility
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
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)
+Locations (1)
| Facility | City | Country | Status |
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| Pfizer Clinical Research Unit | Brussels | Belgium | |
+Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
+Funding