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PF 06835919

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 16, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

PF 06835919 · 1 trial · 1 indication

Phase 1 1
NCT03916406THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTSHealthy Volunteer
COMPLETED10 Analytics
PHASE1COMPLETED
THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS
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Study Endpoints

Primary Endpoints

AUCinf of midazolam following a single oral dose
Baseline up to 51 days

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Secondary Endpoints

AUClast of midazolam following a single oral dose.
Baseline up to 51 days
Cmax of midazolam following a single oral dose.
Baseline up to 51 days
Incidence of Adverse Events in participants
Screening up to 79 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALmidazolam alone followed by combination of PF 06835919 and midazolam
Sequence 2EXPERIMENTALPF 06835919 in combination with midazolam followed by midazolam alone

Interventions

NameTypeDescription
PF 06835919DRUG300 mg
MidazolamDRUG7.5 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiovascular tests. * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). Exclusion Cri...

Countries:Belgium
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Frequently asked questions about PF 06835919

What is PF 06835919 used for?

PF 06835919 is an investigational small molecule being studied for non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD), and hepatic impairment. It has been evaluated in healthy volunteers and in patients with NAFLD and type 2 diabetes mellitus. It is not approved and remains in clinical development.

What does PF 06835919 target?

PF 06835919 is a small molecule being developed by Pfizer. Its molecular target has not been disclosed in available clinical trial information. The drug is being studied for metabolic liver conditions including non-alcoholic steatohepatitis and non-alcoholic fatty liver disease.

Who makes PF 06835919?

PF 06835919 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials evaluating the drug in healthy volunteers and in patients with non-alcoholic fatty liver disease and related conditions.

What phase is PF 06835919 in?

PF 06835919 has completed Phase 1 and Phase 2 clinical trials. The most advanced completed study was a Phase 2 trial in participants with non-alcoholic fatty liver disease and type 2 diabetes mellitus. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF 06835919 in?

PF 06835919 has been studied in four completed clinical trials: NCT02974374, a single ascending dose study in healthy adults; NCT03031119, a multiple ascending dose and drug-drug interaction study; NCT03969719, a Phase 2 study in NAFLD with type 2 diabetes; and NCT04193436, a pharmacokinetic study in hepatic impairment.

Is PF 06835919 the same as PF-06835919?

Yes, PF 06835919 and PF-06835919 refer to the same investigational drug. Clinical trial records use the hyphenated form PF-06835919, while the drug name is also written without a hyphen as PF 06835919. Both names identify the same Pfizer small molecule.