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

NCT02460146 | Completed Phase 1 DMC

• 1 other identifier: CXA-10-202
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events) and tolerability of multiple ascending oral doses of CXA 10 administered daily for 14 days

  14 days

Study Arms (2)

CXA-10

ACTIVE COMPARATOR

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

Drug: CXA-10

CXA-10 placebo

PLACEBO COMPARATOR

The placebo contains olive oil with BHT (0.08% to 0.10%).

Other: CXA-10 placebo

Interventions

CXA-10 DRUG

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid

CXA-10

CXA-10 placebo OTHER

The placebo contains olive oil with BHT (0.08% to 0.10%).

CXA-10 placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Complexa, Inc.: lead

Study Sites (1)

Jasper Clinical Research & Development, Inc.

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

CXA-10

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Thomas Blok, MD

  Jasper Clinic, Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2015
• First Posted: June 2, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)