AzTrials
AzTrials

Healthy VolunteersPhase 1NCT03031119

Multiple Ascending Dose and DDI Study

A Phase 1 study testing PF-06835919 and atorvastatin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PF-06835919 and atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteBelgium
Study dates
Jan 2017to Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit

    Brussels, B-1070

Other trials in Belgium

About this study

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)

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.

Being tested
Placebo, PF-06835919, atorvastatin
Keywords
nonalcoholic steatohepatitis
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • PF-06835919Drug

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

  • atorvastatinDrug

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

Study groups in NCT03031119
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTablets administered once or twice daily, with food, in Part A for 14 days.
Receives: Drug: Placebo
PF-06835919ExperimentalTablets 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.
Receives: Drug: PF-06835919; Drug: atorvastatin
atorvastatinExperimentalIn 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.
Receives: Drug: PF-06835919; Drug: atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Part A

    Measured: Screening to Day 24

  2. Number of Participants With Clinical Laboratory Abnormalities

    Part A

    Measured: Day -2 to Day 24

  3. Change from baseline in vital signs

    Part A

    Measured: Day -1 to Day 24

  4. Change from baseline in 12-lead electrocardiogram

    Part A

    Measured: Day -1 to Day 24

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

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

    Part B

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

Secondary outcomes (26)

  1. Maximum Observed Plasma Concentration (Cmax) on Day 1 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  2. Maximum Observed Plasma Concentration (Cmax) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  3. Maximum Observed Plasma Concentration (Cmax) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48, and 72 hours post-dose

  4. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  5. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  9. Apparent Oral Clearance (CL/F) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  10. Apparent Oral Clearance (CL/F) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  11. Minimum Observed Plasma Trough Concentration (Cmin) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  12. Minimum Observed Plasma Trough Concentration (Cmin) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  13. Accumulation Ratio (Rac) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  14. Accumulation Ratio (Rac) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  15. Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

  16. Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  17. Plasma Decay Half-Life (t1/2) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  18. Apparent Volume of Distribution (Vz/F) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  19. Cumulative Amount of Drug Recovered Unchanged in Urine (Ae) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  20. Percent Cumulative Amount of Drug Recovered Unchanged in Urine (Ae%) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

  21. Renal Clearance (CLr) on Day 14 Part A

    Measured: 0,0.5,1,2,4,5,6,8,12,14,16,24,36,48 and 72 hours post-dose

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

    Part B

    Measured: Screening to Day 18

  23. Number of Participants With Clinical Laboratory Abnormalities

    Part B

    Measured: Day -2 to Day 18

  24. Change from Baseline in Vital Signs

    Part B

    Measured: Day -2 to Day 18

  25. Change from baseline in 12-lead electrocardiogram

    Part B

    Measured: Day -2 to Day 18

  26. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 7 Part A

    Measured: 0,0.5,1,2,4,5,6,8 and 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031119
Sponsor's protocol ID
C1061002
Other IDs
2016-004649-10, 2016
Status last verified
Sep 2017
First submitted
23 Jan 2017
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06835919 and atorvastatin in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Screening to Day 24). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03031119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in