Multiple Ascending Dose and DDI Study

Healthy Volunteers Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031119
• Other study ID #: C1061002
• Secondary ID: 2016-004649-10
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2017
• Last updated: September 5, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Tablets administered once or twice daily, with food, in Part A.
• PF-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.
• atorvastatin
In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Part A	Screening to Day 24
Primary	Number of Participants With Clinical Laboratory Abnormalities	Part A	Day -2 to Day 24
Primary	Change from baseline in vital signs	Part A	Day -1 to Day 24
Primary	Change from baseline in 12-lead electrocardiogram	Part A	Day -1 to Day 24
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A		0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Secondary	Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A		0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Apparent Oral Clearance (CL/F) on Day 7 Part A		0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Secondary	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
Secondary	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
Secondary	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
Secondary	Accumulation Ratio (Rac) on Day 7 Part A		0,0.5,1,2,4,5,6,8 and 12 hours post-dose
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Part B	Screening to Day 18
Secondary	Number of Participants With Clinical Laboratory Abnormalities	Part B	Day -2 to Day 18
Secondary	Change from Baseline in Vital Signs	Part B	Day -2 to Day 18
Secondary	Change from baseline in 12-lead electrocardiogram	Part B	Day -2 to Day 18
Secondary	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

External Links

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