A Study to Evaluate the Effect of Food, Formulation Strength, and a Proton Pump Inhibitor on GED 0301 Pharmacokinetics in Healthy Adult Subjects

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, single-center, 4-period, 6-sequence study in healthy subjects to compare the PK of GED 0301 after a single oral dose in the fed and fasted state, and after co administration with omeprazole, a proton pump inhibitor.

The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow up phone call five days (± 1 day) after discharge.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Omeprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

1. Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 65 years of age the time of signing the ICF.

2. Subject must understand and voluntarily sign an ICF prior to any study related assessments/procedures being conducted.

3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

4. Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.

5. Female subjects NOT of childbearing potential must:

1. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle stimulating hormone [FSH] level of > 40 IU/L at screening).

6. Females of childbearing potential (FCBP) must have a negative pregnancy test at the Screening and Baseline Visits. While receiving investigational product (IP) and for at least 28 days after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy.

OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

7. Male subjects must:

a. Practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 28 days after the last dose of IP, even if he has undergone a successful vasectomy.

8. Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.

9. Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.

10. Subject vitals are as follows:

1. Tympanic body temperature: 35.0 - 37.5°C.

2. Supine blood pressure (BP) after at least 5 minutes supine rest:

i. Systolic BP: 90 - 140 mmHg ii. Diastolic BP: 40 - 90 mmHg c. Supine heart rate (after at least 5 minutes of rest): 40 - 90 beats per minute d. Postural drop (standing BP taken after no more than 1 minute standing) of ≤20 mmHG (systolic) or ≤10 mmHg (diastolic) associated with clinically relevant symptoms.

11. Subject has a normal or clinically acceptable 12 lead ECG at screening. In addition:

1. If male, subject has a QTcF value ≤ 430 msec at screening.

2. If female, subject has a QTcF value ≤ 450 msec at screening.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

1. Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

3. Subject has any condition that confounds the ability to interpret data from the study.

4. Subjects who have:

a. previously been exposed to GED 0301; or b. been exposed to an investigational drug (new chemical entity) within 90 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).

5. Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) in the 14 days prior to the planned admission day.

1. Subject has consumed herbal remedies or dietary supplements containing St. John's Wort, in the three weeks before the planned admission day.

6. Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.

7. Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.

8. Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.

9. Subject has a history or clinical evidence of substance and/or alcohol abuse within the 12 months before screening. Alcohol abuse is defined as regular weekly intake of more than 14 units (using alcohol tracker http://www.nhs.uk/Tools/Pages/NHSAlcoholtracker.aspx).

10. Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.

11. Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self reported).

12. Subject is part of the clinical staff personnel or a family member of the clinical site staff.