Insulin ResistancePhase 1NCT00555451
Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects
A Phase 1 study testing HE3286 in people with Insulin Resistance, run by Harbor Therapeutics at 2 sites in United States.
Trial summary
The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- HE3286
- How many people
- 66 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Sep 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Main Inclusion Criteria:
- Males or females between 18 and 65 years of age
- Body mass index for females between 29 and 35 kg/m2 and no more than 37 kgm2 for males
- Fasting blood glucose level < 126 mg/dL at screening
- 2 hour postprandial (following 75 grams glucose) blood glucose between 140 to 200 mg/dL
- Normal thyroid stimulating hormone with or without thyroid replacement therapy
- Fasting triglycerides < 350 mg/dL
- For females of reproductive potential, agree to avoid pregnancy during the study and for 3 months following study completion, have a negative serum and/or urine pregnancy test, and use an acceptable method of birth control
- Non-smoker or has not smoked for 6 months prior to the screening visit
- No history of alcohol abuse within 2 years
- Negative drug screen at screening and baseline
- Stable weight (+/- 5%); no history of weight loss or gain (> 10% body weight)
- Must provide voluntary, written, informed consent prior to screening evaluations
- Must be able to swallow capsules
Main Exclusion Criteria:
- Marked prolongation of QT/QTc interval or history of additional risk factors for Torsades de Pointes at screening or baseline
- Positive for HIV, HAV, HBV or HCV
- History of clinically significant cardiovascular, hepatic, respiratory or renal or endocrine disorders
- History of breast and/or prostate cancer
- Clinically significant neurological or psychiatric condition, uncontrolled hypertension, clinically significant unstable medical abnormality, chronic disease or active, serious clinical infection or condition
- Personal or family member with breast and/or prostate cancer
- Malignancy within past 5 years except for successfully treated basal cell carcinoma of the skin
- Personal and/or family history of venous thromboembolism
- History of stroke and/or heart attack
- Medication prohibited from study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baton Rouge, Louisiana, 70808
dgd Research, Inc.
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3286 When Administered Orally to Obese Adult Subjects for 28 Days
The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).
Read the detailed description
HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. In these experiments, HE3286 lowered blood glucose levels and prevented progression of hyperglycemia and HE3286 appeared to enhance insulin sensitivity.
- Conditions
- Insulin Resistance
- Being tested
- HE3286
- Keywords
- phase I, safety, tolerance, insulin resistance, obese, pharmacokinetics
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HE3286Drug
Dose escalating cohort driven study. 6 planned cohorts.
- HE3286 5 mg or placebo QD for 28 days;
- HE3286 10 mg (5 mg BID) or placebo BID for 28 days
- HE3286 20 mg (10 mg BID) or placebo BID for 28 days
- HE3286 40 mg (20 mg BID) or placebo BID for 28 days
- HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days
- HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM)
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and pharmacokinetics
Measured: Duration of the study
Secondary outcomes (1)
To assess the potential activity of HE3286 to decrease insulin resistance
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbor Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dwight R. Stickney, MD, Study director, Harbor Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555451
- Sponsor's protocol ID
- HE3286-0102
- Status last verified
- May 2010
- First submitted
- 6 Nov 2007
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Activity of HE3286 When Administered Orally to Obese Adult Subjects for 28 Days
- ClinicalTrials.gov ID
- NCT00555451
- Acronym / sponsor ID
- HE3286-0102
- Conditions
- Insulin Resistance
- Keywords
- phase I, safety, tolerance, insulin resistance, obese, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Harbor TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Nov 2007 (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 objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).
Detailed description
HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. In these experiments, HE3286 lowered blood glucose levels and prevented progression of hyperglycemia and HE3286 appeared to enhance insulin sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HE3286Dose escalating cohort driven study. 6 planned cohorts. 1. HE3286 5 mg or placebo QD for 28 days; 2. HE3286 10 mg (5 mg BID) or placebo BID for 28 days 3. HE3286 20 mg (10 mg BID) or placebo BID for 28 days 4. HE3286 40 mg (20 mg BID) or placebo BID for 28 days 5. HE3286 4 mg (2 mg BID), 20 mg (10 mg BID) or placebo BID for 28 days 6. HE3286 10mg (5 mg BID) for 28 days (open-label cohort in patients with T2DM) | Drug | – |
Primary outcome
safety and pharmacokinetics
Time frame: Duration of the study
1 secondary outcome
To assess the potential activity of HE3286 to decrease insulin resistance
Time frame: duration of study
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 13 May 2010.
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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.
Dwight R. Stickney, MD study director
Harbor Therapeutics
2 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 HE3286 in people with Insulin Resistance, run by Harbor Therapeutics at 2 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?
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 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
safety and pharmacokinetics (time frame: Duration of the study). 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 13 May 2010.