HypercholesterolemiaPhase 1NCT02654899
Single Dose Study of PF-06815345 in Healthy Subjects
A Phase 1 study testing PF-06815345 in people with Hypercholesterolemia, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- PF-06815345
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2015to Mar 2016
- 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 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects
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.
- Conditions
- Hypercholesterolemia
- Being tested
- PF-06815345, Placebo
- Keywords
- Healthy subjects, Single Ascending Dose, Hyperlipidemia, Dyslipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06815345Drug
PF-06815345 will be administered as a liquid dosage formulation
PlaceboOther
Placebo
PF-06815345Drug
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
| Study group | Role | What they receive |
|---|---|---|
| Part 1_Cohort 1_Active; | Experimental | Single ascending dose of PF-06815345 Receives: Drug: PF-06815345 |
| Part 1_Cohort 1_Placebo; | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Part 1_Cohort 2_Active | Experimental | Single ascending dose of PF-06815345 Receives: Drug: PF-06815345 |
| Part 1_Cohort 2_Placebo | Placebo comparator | Single dose of placebo Receives: Other: Placebo |
| Part 2 | Experimental | Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345 Receives: Drug: PF-06815345 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 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
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Maximum Observed Plasma Concentration (Cmax)
Measured: 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
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 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
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06815345
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06815345
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 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 metabolite (PF-06811701)
AUC (0-infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (t-infinity).
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654899
- Sponsor's protocol ID
- C0281001
- Other IDs
- 2015-003935-36, 2015
- Status last verified
- Sep 2018
- First submitted
- 17 Nov 2015
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02654899
- Acronym / sponsor ID
- C0281001
- Conditions
- Hypercholesterolemia
- Keywords
- Healthy subjects, Single Ascending Dose, Hyperlipidemia, Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1_Cohort 1_Active; | Experimental | Drug: PF-06815345Single ascending dose of PF-06815345 |
| Part 1_Cohort 1_Placebo; | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Part 1_Cohort 2_Active | Experimental | Drug: PF-06815345Single ascending dose of PF-06815345 |
| Part 1_Cohort 2_Placebo | Placebo comparator | Other: PlaceboSingle dose of placebo |
| Part 2 | Experimental | Drug: PF-06815345Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-06815345PF-06815345 will be administered as a liquid dosage formulation | Drug | Part 1_Cohort 1_Active;, Part 1_Cohort 2_Active |
| PlaceboPlacebo | Other | Part 1_Cohort 1_Placebo;, Part 1_Cohort 2_Placebo |
| PF-06815345PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation | Drug | Part 2 |
Primary outcome
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 28 days after last dose of study medication
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.
12 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
Time frame: 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
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Time frame: 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
Time frame: 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
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06815345
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06815345
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
Time frame: 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 metabolite (PF-06811701)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Results and safety
The study was stopped early (reason given: Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-06815345 in people with Hypercholesterolemia, 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Sep 2018. 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 was stopped early (reason given: Trial discontinued on 04Apr2016 as a strategic business decision not to pursue the indication. Decision to terminate not due to safety or efficacy concerns.). Results are not available in the source record.
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 Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Baseline (Day 0) up to 28 days after last dose of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2018.