The Safety of a Hypolipidemic Agent in Healthy Normal Volunteers

NCT01930240 | Completed Phase 1

• 1 other identifier: Cortria-002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to assess the blood profile of the N-methylnicotinamide (MNA) following administration of TRIA-662 (N-methylnicotinamide Chloride). The secondary objectives of the study are to characterize the safety and tolerability of TRIA-662 and to assess any potential gender-related differences in the plasma profile of MNA. Changes in serum lipid parameters with particular reference to triglycerides, lipoprotein lipase, and blood pressure effects will also be noted.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• MNA Maximum plasma concentration (Cmax).

  5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints.

  0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.

• Time to plasma MNA Cmax

  5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints.

  0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.

• Area under the plasma MNA concentration curve

  5 mL venous blood samples will be collected by venipuncture at the specified times. These blood samples will be properly processed and analyzed for concentration of MNA and metabolites. The concentration data will undergo typical pharmacokinetic data analysis to arrive at the primary endpoints.

  0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.

Study Arms (3)

TRIA-662 Placebo

PLACEBO COMPARATOR

Single dose of nine placebo capsules matching TRIA-662 drug capsules

Drug: Placebo

TRIA-662 Low Dose

EXPERIMENTAL

Single-dose of TRIA-662 administered as three 30 mg TRIA-662 capsules and six matching placebo capsules

Drug: TRIA-662

TRIA-662 High Dose

EXPERIMENTAL

Single dose of TRIA-662 administered as nine 30mg TRIA-662 capsules

Drug: TRIA-662

Interventions

TRIA-662 DRUG

1-MNA Chloride

Also known as: 1-MNA Chloride

TRIA-662 High Dose; TRIA-662 Low Dose

Placebo DRUG

Double-blind placebo

Also known as: Dummy

TRIA-662 Placebo

Eligibility Criteria

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

You may qualify if:

• Good health (based on medical history, physical examination, electrocardiogram, and clinical laboratory tests)
• Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the Screening visit)
• Between 18 and 50 years old (inclusive)
• Body weight within 20% of the desirable weight for adults at the Screening visit
• Able to execute informed written consent (informed consent must be obtained for all subjects before enrollment in the study.
• Willingness to abstain from alcohol and xanthine-containing food and beverages for the duration of each treatment period
• Willingness to remain in the clinic for the inpatient portions of the study
• Female subjects must be non-pregnant and either surgically sterile, postmenopausal for a least 1 year, or using an acceptable method of contraception defined as an oral, implanted, or transdermal contraceptive plus one of the following barrier methods: diaphragm with spermicidal cream/jelly or use of a condom by sexual partner.

You may not qualify if:

• Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years
• Unwilling or unable to comply with the protocol or reside in the study unit during the study period or to cooperate fully with the principal investigator and site personnel
• Has used any 1) prescription medication within 14 days prior to treatment in either treatment period or 2), or any over-the-counter (OTC) medication, herbal preparations, and/or vitamins within 48 hours prior to the start of study MNA administration on either treatment period of this study.
• Has a clinically abnormal ECG
• Has a serum potassium, sodium, calcium, or magnesium level that is not within normal limits or has other vital signs or clinical laboratory values at the screening visit that are deemed by the principal investigator to make the subject an inappropriate candidate for the study
• Has taken any other investigational drug during the 30 days prior to screening visit
• Has donated or lost more than a unit of blood within 30 days prior to screening visit
• History of renal, hepatic, gastrointestinal, cardiovascular, or hematologic disease
• Serious mental or physical illness within the past year
• Have a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at screening
• Be a female subject with a positive serum pregnancy test or who is breast-feeding at screening
• Be unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available
• Has a history of hypersensitivity or allergic reaction to Niacin or Nicotinamide
• Has had prior exposure to MNA
• Has a Mental capacity that is limited to the extent that the subject cannot provide legal consent or understand information regarding the side effects or tolerance of the study drug.

Sponsors & Collaborators

• Cortria Corporation: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 28, 2013
• Study Start: November 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share