Effects of Smoking, Age and Body Size on Pharmacokinetics, Safety and Tolerability on Tasimelteon in Healthy Subjects

NCT01477619 | Completed Phase 1

• 1 other identifier: VP-VEC-162-1107
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to understand whether there is any difference in the amount of tasimelteon in the blood in smokers versus non-smokers. Additionally, this study will provide an assessment of the effect, if any, of age and body size on the safety and tolerability profile and the pharmacokinetics of tasimelteon.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Tasimelteon plasma concentrations and pharmacokinetics in smokers versus non-smokers

  Plasma concentrations and pharmacokinetics of tasimelteon of group 1 (smokers) will be compared to group 2 (non-smokers)

  Day 1 - Day 2

• To assess the effect of weight, body mass index (BMI), and age on the pharmacokinetic profile of tasimelteon

  Pharmacokinetics of tasimelteon will be compared using all three groups (smokers, non-smokers and elderly). Group 1 and Group 2 will be gender, age and BMI category matched.

  Day 1 -Day 2

Secondary Outcomes (3)

• To assess plasma concentrations and pharmacokinetics of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14) in subjects who smoke compared to subjects who do not smoke.

  Day 1 - Day 2

• To assess the effect of weight, BMI, and age on the pharmacokinetic profile of tasimelteon metabolites (M3, M9, M11, M12, M13, and M14).

  Day 1 - Day 2

• Tasimelteon safety and tolerability

  Day 1

Study Arms (3)

Smokers

EXPERIMENTAL

Split into BMI categories

Drug: Tasimelteon

Non-Smokers

EXPERIMENTAL

Gender, age, and BMI matched to Smokers

Drug: Tasimelteon

Elderly

EXPERIMENTAL

Drug: Tasimelteon

Interventions

Tasimelteon DRUG

20mg single dose on Day 1

Also known as: VEC-162, BMS-214778

Elderly; Non-Smokers; Smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Groups 1 and 2:
• Men or women between 18 - 55 years, inclusive;
• Smokers who test positive for cotinine at screening and baseline and smoke at least 10 cigarettes per day, for at least 6 months prior to screening (Group 1) OR Non-smokers \[abstinence from smoking for at least 6 months before the screening visit and test negative for cotinine at screening and baseline (Group 2)\] who are matched to Group 1 by gender, age (±10 years), and BMI category \[underweight/normal (≤ 24.99), overweight (25.00-29.99), and obese (≥ 30.00)\];
• Males, non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or subject is postmenopausal, without menses for 6 months before screening), or females of child-bearing potential using an acceptable method of birth control for a period of 35 days before the first dosing and females must have a negative pregnancy test at the screening and baseline visits; Note 1: Acceptable methods of birth control include any one of the following: abstinence, vasectomized sexual partner, hormonal methods (i.e. pill, hormonal IUD, Depo-Provera, implants, patch, intravaginal device \[NuvaRing\]), intrauterine device (IUD \[copper banded coils\]), diaphragm, cervical cap, or condom with spermicidal jelly or foam.
• Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
• Body temperature between 35.0-37.5 °C;
• Systolic blood pressure between 90-150 mmHg;
• Diastolic blood pressure between 50-95 mmHg;
• Pulse rate between 50-100 bpm.
• Group 3:
• Men or women 65 years of age or older;
• Non-smokers (abstinence from smoking for at least 6 months before the start of the study and test negative for cotinine at screening and baseline);
• Vital signs (after 3 minutes resting in a semi-supine position) which are within the ranges shown below:
• Systolic blood pressure between 90-160 mmHg;
• Diastolic blood pressure between 50-99 mmHg;

You may not qualify if:

• History of recent (within six months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse or evidence of such abuse as indicated by the laboratory assays conducted during the Screening Visit or at Baseline;
• Any major surgery within three months of Baseline or any minor surgery within one month;
• History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
• Any condition requiring the regular use of medication except those listed in Section 8.2;
• Use of any melatonin preparation chronically within 2 months prior to Day 1 or any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) within 60 days prior to Day 1.
• Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever is longer) of baseline;
• Donation or loss of 400 mL or more of blood within two months prior to the Baseline Visit;
• Significant illness within the two weeks prior to Baseline;
• A known hypersensitivity to tasimelteon or drugs similar to tasimelteon including melatonin;
• Pregnant or lactating females;
• History of liver disease and/or positive for one or more of the following serological results:
• A positive hepatitis C antibody test (anti-HCV)
• A positive hepatitis B surface antigen (HBsAg)
• A positive HIV test result
• Any surgical or medical condition which might significantly alter the absorption, distribution or excretion of any drug. The Investigator should be guided by evidence of any of the following:

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (1)

Bio-Kinetic Clinical Applications

Springfield, Missouri, United States

Location

MeSH Terms

Interventions

tasimelteon

Study Officials

• Vanda Pharmaceuticals

  Vanda Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

US (1)