Type 2 Diabetes MellitusPhase 1NCT02211261

A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

A Phase 1 study testing PF-06293620 in people with Type 2 Diabetes Mellitus, run by Pfizer at 7 sites in United States.

Completed

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

Trial summary

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: PF-06293620
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 7 sitesUnited States
Study dates: 15 Sep 2014to 27 Jan 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Who cannot join

History of Type 1 diabetes mellitus
Evidence of diabetic complications with significant end-organ damage
History of chronic pancreatitis or at high risk for pancreatitis
Poorly controlled hypertension
History of cardiovascular or cerebrovascular event or procedure

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Profil Institute for Clinical Research, Incorporated
Chula Vista, California, 91911
Avail Clinical Research, LLC
DeLand, Florida, 32720
High Point Clinical Trials Center, LLC
High Point, North Carolina, 27265
Orlando Clinical Research Center
Orlando, Florida, 32809
Qps Mra, Llc
South Miami, Florida, 33143
Qps-Mra Llc
South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: PF-06293620, Placebo
Keywords: first in human, single dose, multiple dose, escalation, safety study, Type 2 Diabetes Mellitus
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

PF-06293620Biological
subcutaneous, single dose 0.3 mg/kg
PlaceboBiological
Subcutaneous normal saline single dose
PF-06293620Biological
Subcutaneous, single dose 1.0 mg/kg
PlaceboBiological
Subcutaneous normal saline single dose
PF-06293620Biological
Subcutaneous single dose 3 mg/kg
PlaceboBiological
Subcutaneous normal saline single dose
PF-06293620Biological
Subcutaneous single dose 6 mg/kg
PlaceboBiological
Subcutaneous normal saline single dose
PF-06293620Biological
Intravenous infusion single dose 1 mg/kg
PlaceboBiological
Intravenous infusion normal saline single dose
PF-06293620Biological
Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
PlaceboBiological
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
PF-06293620Biological
Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
PlaceboBiological
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
PF-06293620Biological
Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
PlaceboBiological
Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
PF-06293620Biological
Subcutaneous injection multiple dose TBD mg (Days TBD)
PlaceboBiological
Subcutaneous injection normal saline multiple dose (Days TBD)

Study groups in NCT02211261
Study group	Role	What they receive
Cohort 1-PF-06293620 or placebo	Experimental	Single Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 2-PF-06293620 or placebo	Experimental	Single Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 3-PF-06293620 or placebo	Experimental	Single Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 4-PF-06293620 or placebo	Experimental	Single Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 5-PF-06293620 or placebo	Experimental	Single Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 6-PF-06293620 or placebo	Experimental	Multiple Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 7 PF-06293620 or placebo	Experimental	Multiple Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 8-PF-06293620 or placebo	Experimental	Multiple Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo
Cohort 9-PF-06293620 or placebo	Experimental	Multiple Ascending Dose PF-06293620 or placebo Receives: Biological: PF-06293620; Biological: Placebo

What is being measured

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

Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. 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; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Measured: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
Number of Participants With Dose Limiting or Intolerable Adverse Events
Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
Measured: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Number of Participants With Positive Anti-drug Antibody (ADA) Result
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.
Measured: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Secondary outcomes (21)

Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Clearance (CL) of PF-06293620 (SAD Cohorts)
Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Measured: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Measured: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).
Measured: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Measured: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Measured: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).
Measured: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

Timeline

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

15 Sep 201427 Jan 2017

First posted7 Aug 2014 (estimated)
Study start15 Sep 2014
Primary completion27 Jan 2017
Study completion27 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02211261
Sponsor's protocol ID: B3501001
Status last verified: Oct 2018
First submitted: 6 Aug 2014
Last updated: 16 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02211261
Acronym / sponsor ID: B3501001
Conditions: Type 2 Diabetes Mellitus
Keywords: first in human, single dose, multiple dose, escalation, safety study, Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Sep 2014 (actual)
Primary completion: 27 Jan 2017 (actual)
Study completion: 27 Jan 2017 (actual)
First posted: 7 Aug 2014 (estimated)
Results: Posted 16 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Cohort 1-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboSingle Ascending Dose PF-06293620 or placebo
Cohort 2-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboSingle Ascending Dose PF-06293620 or placebo
Cohort 3-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboSingle Ascending Dose PF-06293620 or placebo
Cohort 4-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboSingle Ascending Dose PF-06293620 or placebo
Cohort 5-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboSingle Ascending Dose PF-06293620 or placebo
Cohort 6-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboMultiple Ascending Dose PF-06293620 or placebo
Cohort 7 PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboMultiple Ascending Dose PF-06293620 or placebo
Cohort 8-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboMultiple Ascending Dose PF-06293620 or placebo
Cohort 9-PF-06293620 or placebo	Experimental	Biological: PF-06293620, Biological: PlaceboMultiple Ascending Dose PF-06293620 or placebo

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening

Key exclusion criteria (5 listed)

History of Type 1 diabetes mellitus
Evidence of diabetic complications with significant end-organ damage
History of chronic pancreatitis or at high risk for pancreatitis
Poorly controlled hypertension
History of cardiovascular or cerebrovascular event or procedure

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-06293620subcutaneous, single dose 0.3 mg/kg	Biological	Cohort 1-PF-06293620 or placebo
PlaceboSubcutaneous normal saline single dose	Biological	Cohort 1-PF-06293620 or placebo
PF-06293620Subcutaneous, single dose 1.0 mg/kg	Biological	Cohort 2-PF-06293620 or placebo
PlaceboSubcutaneous normal saline single dose	Biological	Cohort 2-PF-06293620 or placebo
PF-06293620Subcutaneous single dose 3 mg/kg	Biological	Cohort 3-PF-06293620 or placebo
PlaceboSubcutaneous normal saline single dose	Biological	Cohort 3-PF-06293620 or placebo
PF-06293620Subcutaneous single dose 6 mg/kg	Biological	Cohort 4-PF-06293620 or placebo
PlaceboSubcutaneous normal saline single dose	Biological	Cohort 4-PF-06293620 or placebo
PF-06293620Intravenous infusion single dose 1 mg/kg	Biological	Cohort 5-PF-06293620 or placebo
PlaceboIntravenous infusion normal saline single dose	Biological	Cohort 5-PF-06293620 or placebo
PF-06293620Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)	Biological	Cohort 6-PF-06293620 or placebo
PlaceboSubcutaneous injection normal saline multiple dose (Days 1, 29 and 57)	Biological	Cohort 6-PF-06293620 or placebo
PF-06293620Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)	Biological	Cohort 7 PF-06293620 or placebo
PlaceboSubcutaneous injection normal saline multiple dose (Days 1, 29 and 57)	Biological	Cohort 7 PF-06293620 or placebo
PF-06293620Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)	Biological	Cohort 8-PF-06293620 or placebo
PlaceboSubcutaneous injection normal saline multiple dose (Days 1, 29 and 57)	Biological	Cohort 8-PF-06293620 or placebo
PF-06293620Subcutaneous injection multiple dose TBD mg (Days TBD)	Biological	Cohort 9-PF-06293620 or placebo
PlaceboSubcutaneous injection normal saline multiple dose (Days TBD)	Biological	Cohort 9-PF-06293620 or placebo

Primary outcome

Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events
Time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. 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; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.
Number of Participants With Dose Limiting or Intolerable Adverse Events
Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.
Number of Participants With Positive Anti-drug Antibody (ADA) Result
Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts
ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.

21 secondary outcomes

Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Clearance (CL) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)
Time frame: Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)
Time frame: Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169

Results and safety

Results posted to the registry on 16 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo SC (SAD Cohorts)	9	9
PF-06293620 0.3 mg/kg SC (SAD Cohorts)	6	6
PF-06293620 1.0 mg/kg SC (SAD Cohorts)	6	5
PF-06293620 3.0 mg/kg SC (SAD Cohorts)	6	6
PF-06293620 6.0 mg/kg SC (SAD Cohorts)	9	7
Placebo IV (SAD Cohorts)	2	1
PF-06293620 1.0 mg/kg IV (SAD Cohorts)	6	6
Placebo SC (MAD Cohorts)	8	7
PF-06293620 50 mg SC (MAD Cohorts)	8	8
PF-06293620 75 mg SC (MAD Cohorts)	16	14
PF-06293620 150 mg SC (MAD Cohorts)	8	8

Primary outcome: Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events

Time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.. Number. Unit: participants

Measure	Placebo SC (SAD Cohorts) n = 9	PF-06293620 0.3 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 1.0 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 3.0 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 6.0 mg/kg SC (SAD Cohorts) n = 9	PF-06293620 1.0 mg/kg IV (SAD Cohorts) n = 6	Placebo SC (MAD Cohorts) n = 8	PF-06293620 50 mg SC (MAD Cohorts) n = 8	PF-06293620 75 mg SC (MAD Cohorts) n = 16	PF-06293620 150 mg SC (MAD Cohorts) n = 8
All-causality AE	5	3	3	5	5	3	4	4	11	8
All-causality SAE	0	1	0	0	0	0	0	0	1	2
Treatment-related AE	1	0	0	3	3	1	1	1	4	5
Treatment-related SAE	0	0	0	0	0	0	0	0	0	0

Population analysed: The safety analysis population included all participants who received any amount of dose of study medication.

Primary outcome: Number of Participants With Dose Limiting or Intolerable Adverse Events

Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts

Population analysed: Data for this outcome measure were not collected.

Primary outcome: Number of Participants With Positive Anti-drug Antibody (ADA) Result

Time frame: Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts. Number. Unit: participants

Measure	Placebo SC (SAD Cohorts) n = 9	PF-06293620 0.3 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 1.0 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 3.0 mg/kg SC (SAD Cohorts) n = 6	PF-06293620 6.0 mg/kg SC (SAD Cohorts) n = 9	Placebo IV (SAD Cohorts) n = 2	PF-06293620 1.0 mg/kg IV (SAD Cohorts) n = 6	Placebo SC (MAD Cohorts) n = 8	PF-06293620 50 mg SC (MAD Cohorts) n = 8	PF-06293620 75 mg SC (MAD Cohorts) n = 16	PF-06293620 150 mg SC (MAD Cohorts) n = 8
Value	1	5	2	1	2	0	1	0	5	7	4

Population analysed: The safety analysis population included all participants who received any amount of dose of study medication.

21 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC (SAD Cohorts)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
PF-06293620 0.3 mg/kg SC (SAD Cohorts)	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6
PF-06293620 1.0 mg/kg SC (SAD Cohorts)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
PF-06293620 3.0 mg/kg SC (SAD Cohorts)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
PF-06293620 6.0 mg/kg SC (SAD Cohorts)	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Placebo IV (SAD Cohorts)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
PF-06293620 1.0 mg/kg IV (SAD Cohorts)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Placebo SC (MAD Cohorts)	0 of 8 (0%)	4 of 8 (50%)	0 of 8
PF-06293620 50 mg SC (MAD Cohorts)	0 of 8 (0%)	4 of 8 (50%)	0 of 8
PF-06293620 75 mg SC (MAD Cohorts)	1 of 16 (6.3%)	11 of 16 (68.8%)	0 of 16
PF-06293620 150 mg SC (MAD Cohorts)	2 of 8 (25%)	7 of 8 (87.5%)	0 of 8

Limitations and caveats (from the sponsor): Originally planned 250 mg cohort was not enrolled in MAD part, because 150 mg cohort already demonstrated optimal glucose-lowering effect. Protocol-specified TBD (to be determined) dose level was 50 mg as well as expansion of the 75 mg cohort.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

7 sites 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-06293620 in people with Type 2 Diabetes Mellitus, run by Pfizer at 7 sites in United States.

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 4 inclusion and 5 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (time frame: Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.). The study lists 3 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 NCT02211261.

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 16 Oct 2018.