Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:4/21/2016
Start Date:December 2013
End Date:April 2014

Use our guide to learn which trials are right for you!

A Phase I, Randomized, Double-blind, Placebo-controlled, Rising-dose Study to Assess the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single IV Doses of AR09 in Healthy Subjects

This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV
doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.

Each subject will complete Screening, Baseline, Treatment, and Follow-Up Phases. The
Screening Phase will be conducted on an outpatient basis within 30 days, but no less than 3
days, prior to the start of the Baseline Phase. The Baseline Phase will consist of clinical
research unit (CRU) admission and final qualification assessments. The Treatment Phase will
be comprised of dosing on Day 1, post-treatment safety and pharmacodynamic assessments, and
blood and urine collection. Subjects may be discharged approximately 24 hours after study
drug administration on Day 2, provided the Modified Aldrete Score and all designated
discharge criteria are clinically acceptable to the Investigator. The Follow-Up Phase will
occur on Study Day 5 (± 1 day).

Inclusion Criteria:

- Males/females between 18 to 50 years of age, inclusive;

- Body mass index 18 to 30 kg/m2, inclusive.

- All females must have a negative serum beta human chorionic gonadotropin test result
at screening and a negative urine pregnancy test result at baseline. Female subjects
must be either post-menopausal, surgically sterile or using an acceptable method of
contraception. Acceptable surgical sterilization techniques are hysterectomy,
bilateral tubal ligation with surgery at least 6 months prior to dosing and bilateral
oophorectomy with surgery at least 2 months prior to dosing. Acceptable methods of
contraception are an intrauterine device, contraceptive implant, oral contraceptive
(stable dose of the same hormonal contraceptive product for at least 12 weeks prior
to dosing), a vasectomized partner and a double-barrier method (condom + spermicide /
diaphragm + spermicide).

- Willing and able to provide voluntary, written informed consent.

Exclusion Criteria:

- Acute illness within 2 weeks prior to dosing;

- History of any chronic illness or evidence of significant organic or psychiatric
disease on medical history or physical examination which, in the opinion of the
Investigator would confound the study results or present a risk to the subject;

- History of any clinically significant pulmonary conditions, within the last 2 years
requiring admission to the hospital;

- Spirometry forced expiratory volume in one second (FEV1) and forced vital capacity
(FVC) ratio less than 70%;

- If female, pregnant or lactating;

- Clinically significant illness or abnormality on physical examination, or ECG,
including measure of the time between the start of the Q wave and the end of the T
wave in the heart's electrical cycle (QTc interval) >440 msec, on Screening or
pre-dose 12-lead ECG;

- Resting heart rate while awake < 45 or > 90 b/m;

- Laboratory value(s) outside the laboratory reference range considered clinically
significant (clinical chemistry, hematology, coagulation, ACTH, urinalysis, or
pregnancy test).

- Presence of type I or type II diabetes;

- History of a severe allergic reaction to any drug or multiple food/drug allergies;

- Subjects with a formal diagnosis obstructive sleep apnea or having a score of >3 on
the STOP-Bang questionnaire (see Appendix 4);

- Reported chronic (regular use for >1 month) use of medication of any kind (except
contraceptives as described in the inclusion criteria), unless approved by the
Sponsor;

- Reported use of any prescription drug within 14 days prior to dosing, any
non-prescription drug or vitamin within 7 days prior to dosing, any known
enzyme-inducer, enzyme-inhibitor, or other investigational drug within 30 days prior
to dosing, or reported chronic exposure to enzyme-inducers such as paint solvents or
pesticides within 30 days of dosing, unless approved by the Sponsor; hormonal
contraceptive will be permitted if the subject has been using it for at least 12
weeks prior to dosing;

- History of alcohol or illicit drug abuse within the past two years, or current
reported average alcohol intake > two alcoholic drinks per day (e.g., more than 24
oz. of beer, 10 oz. of wine, or 3 oz. of hard liquor);

- Regular use of tobacco or nicotine containing products within 1 year of study entry;

- Average consumption of ≥ 6 caffeine containing beverages per day;

- Consumption of alcohol within 72 hours prior to dosing, or a positive qualitative
urine drug or cotinine screen, or positive oral screen for the presence of alcohol;

- Consumption of herbal supplements, grapefruit or grapefruit juice within 14 days
before dosing;

- Blood donation of approximately 400 mL or more within 4 weeks or plasma donation
within 2 weeks prior to dosing;

- Received an investigational product within 30 days of first dose in this study.
We found this trial at
1
site
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials