HealthyPhase 1Cortria-002NCT01930240

The Safety of a Hypolipidemic Agent in Healthy Normal Volunteers

A Phase 1 study testing TRIA-662 in people with Healthy, run by Cortria Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: TRIA-662
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: No sites listed yet
Study dates: Nov 2007to Jan 2008
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 16Show fewer

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
Has any condition(s) that in the investigator's opinion would: a) warrant exclusion from the study or b) prevent the subject from completing the study
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.

About this study

Official title: A Randomized Placebo Controlled Double Blind Two Period Cross-Over Study to Assess the Safety and Pharmacokinetics and Pharmacodynamics of Oral Dosages of TRIA-662 (A Hypolipidemic Agent) in Healthy Volunteers

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.

Read the detailed description

A total of 20 subjects volunteers (10 male and 10 female) will receive the following treatments administered in a randomized fashion with 2 embedded placebo dosages in each group (8 active Males and 8 active females with 2 placebo males and females):

DRUG (Low Dose): Single therapeutic dose of MNA administered as a 90 mg oral dose
DRUG (High Dose): Single therapeutic dose of MNA administered as a 270 mg oral dose
PLACEBO: Placebo for MNA administered as an identically appearing oral dose Each treatment period will consist of a 3-day two-night confinement cycle with admission on day 1, treatment on day 1 with a single dose of active or placebo with discharge 24 hours following the last assessment the next morning. A washout period of 5 days will separate each treatment period. Standard biochemical and clinical baseline medical background and physical examination will occur at screening and at Day -1 to assess/confirm entry criteria. During each treatment period, serial plasma samples (n=12) for MNA assay will be collected on the treatment day. Safety assessments, including vitals signs (blood pressure, pulse rate, respiration rate, and oral body temperature), will be performed at screening, at baseline, and at 4 times throughout each treatment period. Physical examinations and standard clinical laboratory tests (hematology, serum chemistry, and urinalysis) will be obtained at screening, and at admission for each treatment period, and prior to subject's final discharge from the study. The Lunch meals on the dosing day will be identical in each subject on each occasion.

The pharmacokinetic and safety assessments will be performed at specified times prior to and after study MNA administration.

Conditions: Healthy
Being tested: TRIA-662, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TRIA-662Drug
Also called 1-MNA Chloride
1-MNA Chloride
PlaceboDrug
Also called Dummy
Double-blind placebo

Study groups in NCT01930240
Study group	Role	What they receive
TRIA-662 Placebo	Placebo comparator	Single dose of nine placebo capsules matching TRIA-662 drug capsules Receives: 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 Receives: Drug: TRIA-662
TRIA-662 High Dose	Experimental	Single dose of TRIA-662 administered as nine 30mg TRIA-662 capsules Receives: Drug: TRIA-662

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Jan 2008

First posted28 Aug 2013 (estimated)
Study startNov 2007
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01930240
Sponsor's protocol ID: Cortria-002
Acronym: Cortria-002
Status last verified: Jul 2016
First submitted: 21 Aug 2013
Last updated: 26 Jul 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Placebo Controlled Double Blind Two Period Cross-Over Study to Assess the Safety and Pharmacokinetics and Pharmacodynamics of Oral Dosages of TRIA-662 (A Hypolipidemic Agent) in Healthy Volunteers
ClinicalTrials.gov ID: NCT01930240
Acronym / sponsor ID: Cortria-002 / Cortria-002
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Cortria CorporationIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 28 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

DRUG (Low Dose): Single therapeutic dose of MNA administered as a 90 mg oral dose
DRUG (High Dose): Single therapeutic dose of MNA administered as a 270 mg oral dose
PLACEBO: Placebo for MNA administered as an identically appearing oral dose Each treatment period will consist of a 3-day two-night confinement cycle with admission on day 1, treatment on day 1 with a single dose of active or placebo with discharge 24 hours following the last assessment the next morning. A washout period of 5 days will separate each treatment period. Standard biochemical and clinical baseline medical background and physical examination will occur at screening and at Day -1 to assess/confirm entry criteria. During each treatment period, serial plasma samples (n=12) for MNA assay will be collected on the treatment day. Safety assessments, including vitals signs (blood pressure, pulse rate, respiration rate, and oral body temperature), will be performed at screening, at baseline, and at 4 times throughout each treatment period. Physical examinations and standard clinical laboratory tests (hematology, serum chemistry, and urinalysis) will be obtained at screening, and at admission for each treatment period, and prior to subject's final discharge from the study. The Lunch meals on the dosing day will be identical in each subject on each occasion.

The pharmacokinetic and safety assessments will be performed at specified times prior to and after study MNA administration.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
TRIA-662 Placebo	Placebo comparator	Drug: PlaceboSingle dose of nine placebo capsules matching TRIA-662 drug capsules
TRIA-662 Low Dose	Experimental	Drug: TRIA-662Single-dose of TRIA-662 administered as three 30 mg TRIA-662 capsules and six matching placebo capsules
TRIA-662 High Dose	Experimental	Drug: TRIA-662Single dose of TRIA-662 administered as nine 30mg TRIA-662 capsules

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TRIA-662Also: 1-MNA Chloride1-MNA Chloride	Drug	TRIA-662 High Dose, TRIA-662 Low Dose
PlaceboAlso: DummyDouble-blind placebo	Drug	TRIA-662 Placebo

Primary outcome

MNA Maximum plasma concentration (Cmax).
Time frame: 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.
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.
Time to plasma MNA Cmax
Time frame: 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.
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.
Area under the plasma MNA concentration curve
Time frame: 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TRIA-662 in people with Healthy, run by Cortria Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MNA Maximum plasma concentration (Cmax). (time frame: 0, 1, 2, 3, 4, 5, 8, 12, 18, 24 hours after dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01930240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.