Expired Study
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Kalamazoo, Michigan 49007


Purpose:

The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese male volunteers.


Study summary:

Complexa has developed an oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as multiple ascending oral doses over 14 days to healthy obese male volunteers. The pharmacodynamic (PD) effects of CXA-10 on serum biomarkers, some of which are elevated in the obese population, will also be investigated.


Criteria:

Inclusion Criteria: - Body mass index (BMI) >27 and ≤40 kg/m2 - In good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation - Results of clinical laboratory tests must be without clinically significant abnormalities for this population and may exceed the limits of the reference ranges, including hematology, clinical chemistry and urinalysis except as noted below - Hemoglobin A1c (HbA1c) <7% - Average blood pressure <160/100 mmHg at screening - QTcF interval (Fredericia's correction factor) must be ≤430 msec at screening and pre-dose Exclusion Criteria: - Any clinically relevant abnormality for this population identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study - Any clinical history of cardiovascular events, arrhythmias, fainting, palpitations, personal or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason - History of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years - History of regular alcohol consumption exceeding 21 units/week (one unit = 125 mL of wine or 284 mL of beer or a single 25 mL measure of spirits) within 6 months of screening - Treatment with any prescription or non-prescription drugs (including vitamins, herbal and dietary supplements) within 7 days or 5 half-lives, whichever is longer, prior to dosing and until collection of the final PK sample. Use of any drug including aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) must be avoided within 7 days prior to the first dose and during this study as it may interfere with the pharmacology of CXA-10. Use of high energy supplements or drinks (especially, those containing caffeine, protein supplements, and weight loss drugs) - History of smoking, including e-cigarettes, or use of nicotine-containing products within 1 month of screening - Resting heart rate ≥100 BPM after 5 minutes rest (as above) at the screening visit - Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study - Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)


Study is Available At:


Original ID:

CXA-10-202


NCT ID:

NCT02460146


Secondary ID:


Study Acronym:


Brief Title:

PK and PD of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects


Official Title:

A Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Sequential Multiple Ascending, Repeat Doses of Oral CXA-10 in Healthy Obese Male Subjects


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Complexa, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

43


Enrollment Type:

Actual


Overall Contact Information

Official Name:Thomas Blok, MD
Principal Investigator
Jasper Clinic, Michigan

Study Dates

Start Date:April 2015
Completion Date:October 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:May 2016
Last Changed Date:May 2, 2016
First Received Date:May 3, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety (adverse events) and tolerability of multiple ascending oral doses of CXA 10 administered daily for 14 days
Time Frame:14 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CXA-10
Description:CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
Arm Name:CXA-10
Intervention Type:Other
Name:CXA-10 placebo
Description:The placebo contains olive oil with BHT (0.08% to 0.10%).
Arm Name:CXA-10 placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:CXA-10 placebo
Description:The placebo contains olive oil with BHT (0.08% to 0.10%).
Study Arm Type:Active Comparator
Arm Name:CXA-10
Description:CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Complexa, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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