Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
NCT ID: NCT00970593
Last Updated: 2020-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
92 participants
INTERVENTIONAL
2009-09-02
2011-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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OAP-189
OAP-189
Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation)
2
placebo comparator
Group 1 \& 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days
Interventions
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OAP-189
Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation)
placebo comparator
Group 1 \& 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days
Eligibility Criteria
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Inclusion Criteria
* Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.
* Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight \>=50 kg.
* Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
* Subjects must currently be treated for diabetes with metformin alone at a total daily dose of \>=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.
* Nonsmoker.
Exclusion Criteria
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
* Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
* Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
* Positive findings of urine drug screen
* Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Profil Institute for Clincal Research
Chula Vista, California, United States
Cetero Research - Miami
Miami Gardens, Florida, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2201004
Identifier Type: OTHER
Identifier Source: secondary_id
3283K1-1008
Identifier Type: -
Identifier Source: org_study_id