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

• ClinicalTrials.gov Identifier: NCT02460146
• Recruitment Status: Completed
• First Posted: June 2, 2015
• Last Update Posted: May 3, 2016
• Sponsor: Complexa, Inc.
• Information provided by (Responsible Party): Complexa, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Kidney Injury	Drug: CXA-10; Other: CXA-10 placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: April 2015
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

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%).

Outcome Measures

Primary Outcome Measures :

1. Safety (adverse events) and tolerability of multiple ascending oral doses of CXA 10 administered daily for 14 days [ Time Frame: 14 days ]

Eligibility Criteria

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

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)

Contacts and Locations

Locations

United States, Michigan

Jasper Clinical Research & Development, Inc.

Kalamazoo, Michigan, United States, 49007

Sponsors and Collaborators

Complexa, Inc.

Investigators

• Principal Investigator: Thomas Blok, MD; Jasper Clinic, Michigan

More Information

• Responsible Party: Complexa, Inc.
• ClinicalTrials.gov Identifier: NCT02460146
• Other Study ID Numbers: CXA-10-202
• First Posted: June 2, 2015
• Last Update Posted: May 3, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases