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

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

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 Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: CXA-10; Other: CXA-10 placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Jasper Clinical Research & Development, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CXA-10; CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid	Drug: CXA-10; CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
Placebo Comparator: CXA-10 placebo; The placebo contains olive oil with BHT (0.08% to 0.10%).	Other: CXA-10 placebo; The placebo contains olive oil with BHT (0.08% to 0.10%).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Complexa, Inc.
• Investigators: Principal Investigator: Thomas Blok, MD, Jasper Clinic, Michigan

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 3, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Anti-Inflammatory Agents; CXA-10
• Other Study ID Numbers: CXA-10-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO