Eligibility |
Inclusion Criteria:
1. Healthy male and female, non-smoking, subjects between the ages of 18 and 55 years,
inclusive, at the time of screening.
2. Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive and weigh at least
50 kg and no more than 100 kg inclusive.
3. Good general health, as determined by an experienced physician based on a medical
evaluation including detailed medical history, full physical examination, including
blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG) and
clinical laboratory tests.
4. Male subjects and their female spouse/partner(s) who are of childbearing potential:
1. Must agree to stay abstinent (where abstinence is the preferred and usual
life-style of the subject), starting at screening and continuing throughout the
clinical study period, and for 90 days after study drug administration.
Or
2. Must be using highly effective contraception consisting of 2 forms of birth
control (1 of which must be a barrier method) starting at screening and
continuing throughout the clinical study period, and for 90 days after study drug
administration.
3. These requirements do not apply to participants in a same sex relationship.
5. Male subjects must agree not to donate sperm starting at screening and continuing
throughout the clinical study period, and for 90 days after study drug administration.
6. Female subjects of childbearing potential:
1. Must agree not to become pregnant during the clinical study period and for 30
days after study drug administration.
2. Must have a negative serum pregnancy test at screening.
3. If heterosexually active, must agree to consistently use a form of highly
effective birth control, in combination with a barrier method starting at
screening and continuing throughout the clinical study period, and for 30 days
after study drug administration
Or
4. Must agree to stay abstinent, (where abstinence is the preferred and usual
life-style of the subject), starting at screening and continuing throughout the
clinical study period, and for 30 days after study drug administration.
5. These requirements do not apply to participants in a same sex relationship.
7. Female subjects of non-childbearing potential:
1. Must have a confirmed clinical history of sterility
Or
2. Must be postmenopausal as defined as: amenorrhea for at least 1 year prior to
screening and a laboratory confirmed serum follicle stimulating hormone (FSH)
level = 40mIU/mL.
8. Female subjects must agree not to breastfeed starting at screening and continuing
throughout the clinical study period, and for 90 days after study drug administration.
9. Female subjects must agree not to donate ova starting at screening and continuing
throughout the clinical study period, and for 90 days after study drug administration.
10. Subject must be competent to understand the nature of the study & capable of giving
written informed consent. Be willing to report for the scheduled study visits and
communicate to study personnel about adverse events and concomitant medication use.
11. Subject must abstain from the following foods from 1 week prior to study drug
administration until the last PK sample has been obtained: grapefruit juice or
products, pomegranate juice or products, foods containing poppy seeds, and/or drinks
or foods containing quinine (e.g., tonic water) or Seville oranges (e.g., orange
marmalade).
12. Subject agrees not to participate in another interventional study while participating
in the present clinical study.
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Exclusion Criteria:
1. Female subject who has been pregnant within the 6 months prior to screening or
breastfeeding within the 3 months prior to screening.
2. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies
and childhood asthma) at time of study drug administration.
3. Current or chronic history of gastrointestinal illness or conditions interfering with
normal gastrointestinal anatomy or motility. Examples include gastrointestinal bypass
surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small
bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis,
irritable bowel syndrome (IBS) or celiac sprue.
4. Treatment with any anti-platelet and/or anticoagulant medication.
5. Evidence or history of specific food intolerance. Examples include gluten intolerance,
lactose intolerance, or dairy food intolerance or any food/ingredient included in the
protein breakfast.
6. A positive result, on screening, for serum hepatitis B surface antigen (HBsAg),
hepatitis A virus antibodies (HAV), hepatitis C virus antibodies (HCV) or antibodies
to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2).
7. A positive pre-study drug/alcohol screen. However, there is the option to re-screen
during the screening period at the discretion of the PI or delegate in the case of a
positive pre-study drug screen for a prescribed medication e.g. codeine.
8. Subject has a history of drinking > 21 units of alcohol/week for male subjects or > 14
units of alcohol/week for female subjects within the 3 months prior to screening.
9. Subject has a history of regular smoking (daily or most days in a week) or the use of
nicotine products (3 or more nicotine-containing products) within the 6 months prior
to screening.
10. Subjects who show evidence of use of any recreational drugs of abuse on testing or
recent history (within the 3 months prior to screening).
11. Subject has a pulse rate <40 or > 100 bpm; mean systolic blood pressure (SBP) > 140
mmHg; mean diastolic blood pressure (DBP) > 90 mmHg at screening. Repeat measurements
are allowed at the discretion of the PI or delegate.
12. Subject has any clinically significant abnormalities at screening in rhythm,
conduction or morphology of the resting ECG and any clinically significant
abnormalities in the 12-lead ECG, as considered by the Investigator, that may
interfere with the interpretation of QTc interval changes including abnormal ST-T wave
morphology.
13. Subject has prolonged QTcF (QT interval corrected for heart rate using Fridericia's
formula) > 450 ms for male subjects or > 470 ms for female subjects, or shortened QTcF
< 300 ms or a family history of prolonged QT syndrome, at screening.
14. Subject has any clinically significant abnormalities in clinical chemistry,
hematology, or urinalysis at screening as judged by the Investigator, including:
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase
(ALP), gamma glutamyl transferase (GGT) or Total bilirubin (TBL) more than 1.5 times
the Upper Limit of Normal (ULN).
15. Plasma donation within the 14 days prior to screening or any whole blood
donation/significant blood loss > 500 mL during the 3 months prior to screening.
16. Treatment with any Investigational Drug or Device/Treatment within the 30 days prior
to the administration of study drug.
17. Use of any prescribed or non-prescribed medication including, herbal and dietary
supplements, antacids, analgesics (other than oral contraceptives, paracetamol or
multi-vitamins) during the two weeks prior to the administration of the study drug, or
up to a minimum of 5 times the half-life of the medication if it has a long half-life.
18. Previous treatment with CDX-6114 active study drug (but not placebo) in study
CDX6114-001.
19. Known allergy or adverse reaction history to any of the oral dose formulation
components e.g. mannitol
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