Diabetes Mellitus, Type 2Phase 1NCT01427257
Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study testing Single Dose PB1023 in people with Diabetes Mellitus, Type 2, run by PhaseBio Pharmaceuticals Inc. at 1 site in United States.
Trial summary
Primary objective: To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations). Secondary objectives: To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Single Dose PB1023
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign a written informed consent and follow all study related procedures.
- Males or post menopausal or surgically sterile females age 18 - 75 years of age inclusive.
- Diagnosed with T2DM for ≥ 6 months.
- HbA1c of ≥ 6.0% if diet and exercise controlled, or ≥5.8% if taking one or more glucose lowering agents
- Weight ≥ 45 kg and BMI ≤ 40 kg/m2
- In otherwise stable health except for T2DM (no clinically significant laboratory abnormalities, vital signs, ECG findings or clinically significant underlying disease that would put the subject at risk for participation in the study).
- Receiving stable doses of concomitant medications for 30 days prior to dosing.
- Criteria for Participation in Period 3 only: Received PB1023 Injection at 50 mg/mL and 100 mg/mL during Period 1 or 2 of the study and had adequate pharmacokinetic samples collected for evaluation of their pharmacokinetic profile.
Who cannot join
- Currently taking Byetta® or Victoza®.
- Previously received PB1023 Injection other than under this study protocol.
- Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
- Unstable cardiovascular disease defined as:
- History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to the Screening visit.
- Screening (duplicate supine reading) BP ≥ 160 mmHg (systolic) or ≥ 100 mmHg (diastolic).
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- Mean triplicate 12-lead ECG demonstrating QT interval (corrected) (QTc) > 450 msec in males and > 470 msec in females at the Screening visit, or a history or evidence of long QT syndrome.
- Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have:
- History, symptoms or signs of pancreatitis or severe gastrointestinal disease (i.e., gastroparesis)
- Personal or family history of medullary thyroid tumors or history of Multiple Endocrine Neoplasia Syndrome Type 2. Note: Abnormal serum calcitonin at screening will exclude the subject from participation.
- Clinically significant renal and/or hepatic dysfunction at screening as indicated by the following:
- eGFR as calculated by MDRD of < 60 mL/min
- Urine dipstick protein > 2+ (100 mg/dL) or urine protein 2+ and a Urine Protein/Creatinine ratio > 1.0 (> 1000 mg/g)
- Alanine aminotransferase (ALT) > 2 x ULN
- Aspartate aminotransferase (AST) > 2 x ULN
- Serum bilirubin ≥ 1.6 mg/dL
- Pregnant or lactating females
- Known history of or active alcohol or drug abuse within 12 months prior to Screening or positive alcohol and/or drug screen.
- Positive for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C Virus (HCV) antibodies.
- Participating in any other study and have received any other investigational drug or device within 30 days prior to the Screening visit or are taking part in a non-drug study which in the opinion of the Investigator would interfere with the outcome of the study.
- Other medical (i.e., acute or chronic illness) or psychiatric condition which in the opinion of the Investigator would place the subject at increased risk, confound the primary study endpoint, or would preclude obtaining voluntary consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Open-Label Two-Way Cross Over Study to Assess the Pharmacokinetic Profile of Two Formulations of PB1023 Injection Following a Single Dose Administered By Subcutaneous Injection in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)
Primary objective:
To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations).
Secondary objectives:
To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM.
To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Single Dose PB1023
- 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.
Single Dose PB1023Drug
Single Dose PB1023 Formulation A
Single Dose PB1023Drug
Single Dose PB1023 Formulation B
Single Dose PB1023Drug
Single Dose PB1023 Formulation B
| Study group | Role | What they receive |
|---|---|---|
| PB1023 Formulation A | Active comparator | Not described Receives: Drug: Single Dose PB1023 |
| PB1023 Formulation B | Active comparator | Not described Receives: Drug: Single Dose PB1023 |
| PB1023 Formulation B (2-8C) | Active comparator | Not described Receives: Drug: Single Dose PB1023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
The pharmacokinetic profile of two formulations of PB1023 will be compared. The following parameters will be evaluated: t1/2, AUC(inf), AUC(0-t), Tmax, Cmax, Elimination Rate Constant, Clearance and Distribution.
Measured: For each dosing period: Pre-dose, 1, 4, 8, 12 hours, 1, 2, 3, 4, 7 and 10 days post-dose
Secondary outcomes (1)
Safety/Tolerability
Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, M.D., Principal investigator, Prism Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427257
- Sponsor's protocol ID
- PB1023-PT-CL-0002
- Status last verified
- Sep 2012
- First submitted
- 29 Aug 2011
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Open-Label Two-Way Cross Over Study to Assess the Pharmacokinetic Profile of Two Formulations of PB1023 Injection Following a Single Dose Administered By Subcutaneous Injection in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT01427257
- Acronym / sponsor ID
- PB1023-PT-CL-0002
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PhaseBio Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 1 Sep 2011 (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.
Primary objective:
To compare the pharmacokinetic profile of PB1023 after a single dose administered by subcutaneous injection of two formulations (concentrations).
Secondary objectives:
To evaluate the safety and tolerability of two formulations of PB1023 Injection administered as a subcutaneous injection in adult subjects with T2DM.
To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PB1023 Formulation A | Active comparator | Drug: Single Dose PB1023 |
| PB1023 Formulation B | Active comparator | Drug: Single Dose PB1023 |
| PB1023 Formulation B (2-8C) | Active comparator | Drug: Single Dose PB1023 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to sign a written informed consent and follow all study related procedures.
- Males or post menopausal or surgically sterile females age 18 - 75 years of age inclusive.
- Diagnosed with T2DM for ≥ 6 months.
- HbA1c of ≥ 6.0% if diet and exercise controlled, or ≥5.8% if taking one or more glucose lowering agents
- Weight ≥ 45 kg and BMI ≤ 40 kg/m2
Key exclusion criteria (21 listed)
- Currently taking Byetta® or Victoza®.
- Previously received PB1023 Injection other than under this study protocol.
- Known allergy or serious adverse effect to an approved or investigational GLP-1 receptor analog/agonist.
- Unstable cardiovascular disease defined as:
- Based on contraindications/warnings identified with other GLP-1 receptor agonists, subjects will be excluded if they have:
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 |
|---|---|---|
| Single Dose PB1023Single Dose PB1023 Formulation A | Drug | PB1023 Formulation A |
| Single Dose PB1023Single Dose PB1023 Formulation B | Drug | PB1023 Formulation B |
| Single Dose PB1023Single Dose PB1023 Formulation B | Drug | PB1023 Formulation B (2-8C) |
Primary outcome
Pharmacokinetics
Time frame: For each dosing period: Pre-dose, 1, 4, 8, 12 hours, 1, 2, 3, 4, 7 and 10 days post-dose
The pharmacokinetic profile of two formulations of PB1023 will be compared. The following parameters will be evaluated: t1/2, AUC(inf), AUC(0-t), Tmax, Cmax, Elimination Rate Constant, Clearance and Distribution.
1 secondary outcome
Safety/Tolerability
Time frame: 42 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
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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.
Mark Matson, M.D. principal investigator
Prism Research
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 Single Dose PB1023 in people with Diabetes Mellitus, Type 2, run by PhaseBio Pharmaceuticals Inc. at 1 site 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 8 inclusion and 21 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 1 Oct 2012. 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 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?
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?
Pharmacokinetics (time frame: For each dosing period: Pre-dose, 1, 4, 8, 12 hours, 1, 2, 3, 4, 7 and 10 days post-dose). 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 1 Oct 2012.