Oral Tyramine Pressor Response Study of CX157 Tablets in Healthy Male Volunteers

NCT01633437 | Completed Phase 1

• 1 other identifier: CX157-112
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study were to examine the cardiovascular sensitivity to oral tyramine after establishment of steady state with CX157 Modified Release (MR) Tablets, 125 mg administered twice per day (BID) in healthy volunteers compared to placebo; and to investigate the general safety, tolerability and pharmacokinetic profile of CX157 tablets at steady state compared to placebo.

Conditions

Major Depressive Disorder

Keywords

tyramine; MAOI; cheese effect; depression

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure (SBP)

  SBP was measured every 5 minutes for the first two hours and every 15 minutes for the next two hours post tyramine ingestion on study Days 10 (20 mg tyramine), 11 (40 mg tyramine), and 12 (80 mg tyramine).

  4 hours post dose on study Days 10, 11, 12

Secondary Outcomes (2)

• Number of subjects with adverse events as a measure of safety and tolerability of CX157.

  Study Days 4-12 (during the DB study drug administration)

• Cmax, Cmin, Tmax

  Study Days 6-12

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Other: Placebo

CX157

EXPERIMENTAL

CX157 is a reversible monoamine oxidase inhibitor (RIMA) in Phase II development for the treatment of depression.

Drug: CX157

Interventions

CX157 DRUG

CX157 Modified Release Tablet 125 mg administered twice per day on study days 4-11 and in the morning of study day 12.

CX157

Placebo OTHER

Placebo administered twice per day on study days 4-11 and in the morning of day 12.

Sugar pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male between 18 to 50 years of age, inclusive.
• In good general health as ascertained by not clinically significant physical examination (PE) including measurement of vital signs, medical history, clinical laboratory studies, and 12-lead electrocardiogram (ECG).
• Body Mass Index (BMI) ≥22 and ≤30 kg/m2.
• Agree to abstain from consuming either alcohol-containing or caffeine-containing beverages and to adhere to the dietary restrictions.

You may not qualify if:

• Presence of a significant acute or chronic medical disorder.
• The mean of three consecutive semi-recumbent SBP and diastolic blood pressure (DBP) readings taken five minutes apart over a 10-minute period at Screening and Day -1 exceeds 140 mmHg and 90 mmHg, respectively, and/or is not stable (semi-recumbent SBP exceeds a maximum range of 10 mmHg between the lowest and highest value).
• The mean of three consecutive semi-recumbent SBP and DBP readings taken five minutes apart over a 10-minute period at Screening and Day -1 is \<90 mmHg and 60 mmHg, respectively.
• Has the requirement for or use of any prescription medications within 35 days of study initiation or anticipates use of any psychoactive medication during the study.
• Has taken an monoamine oxidase inhibitor (MAOI) within 90 days preceding Period 1, Day 1 of the study.
• Has requirement for any medication contraindicated for use with an MAOI.
• Use of any over-the-counter (OTC) medication within 14 days of study drug.
• History of substance abuse or dependence, including alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, within the past 12 months.
• Use of tobacco products or any nicotine-containing products (e.g., gum, patch) currently or within the prior 6 months.
• Subject is unwilling to stop consumption of alcohol or caffeine/xanthine-containing drinks or foods within 72 hours of dosing of Day 1 (including any type of wines, caffeinated or decaffeinated herbal tea, grapefruit products (e.g., fresh, canned, or frozen), Seville oranges and pomelos).
• Subjects with known adverse events associated with ingestion of tyramine-containing food.
• Subjects with contraindications to administration of adrenergic receptor antagonists such as labetalol (e.g., asthma, obstructive airway disease, severe bradycardia, diabetes).
• Abnormal screening medical/physical examination, unless the abnormality is considered unlikely to be affected by study participation, or to confound interpretation of safety data.
• A clinically significant clinical laboratory or ECG abnormality at screening; includes any of the following:
• Aspartate aminotransferase (AST/SGOT) \>2.0 x the upper limit of normal (ULN),

Sponsors & Collaborators

• CeNeRx BioPharma Inc.: lead

Study Sites (1)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

CX157

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• William Gerson, D.O.

  Comprehensive Phase One

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 4, 2012
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 4, 2012

Record last verified: 2012-06

Locations

US (1)