NCT02654899

Brief Summary

The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

4 months

First QC Date

November 17, 2015

Last Update Submit

September 26, 2018

Conditions

Hypercholesterolemia

Keywords

Healthy subjectsSingle Ascending DoseHyperlipidemiaDyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

    Baseline (Day 0) up to 28 days after last dose of study medication

Secondary Outcomes (12)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345

    0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345

    0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

  • Maximum Observed Plasma Concentration (Cmax) for PF-06815345

    0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

  • Time to Reach Maximum Observed Concentration for PF-06815345

    0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

  • Plasma Decay Half-Life (t1/2) for PF-06815345

    0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose

  • +7 more secondary outcomes

Study Arms (5)

Part 1_Cohort 1_Active;

EXPERIMENTAL

Single ascending dose of PF-06815345

Drug: PF-06815345

Part 1_Cohort 1_Placebo;

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Part 1_Cohort 2_Active

EXPERIMENTAL

Single ascending dose of PF-06815345

Drug: PF-06815345

Part 1_Cohort 2_Placebo

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

Part 2

EXPERIMENTAL

Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345

Drug: PF-06815345

Interventions

PF-06815345DRUG

PF-06815345 will be administered as a liquid dosage formulation

Part 1_Cohort 1_Active;Part 1_Cohort 2_Active
PlaceboOTHER

Placebo

Part 1_Cohort 1_Placebo;Part 1_Cohort 2_Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and female of non-childbearing potential;
  • Age of 18-55, inclusive;
  • Body Mass Index 17.5-34.9 kg/m2, inclusive;
  • Body weight \>50 kg;
  • Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

You may not qualify if:

  • \- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemiasDyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

January 13, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations

BE(1)