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

NCT02957474 | Completed Phase 1

• 1 other identifier: GED-0301-CP-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Pharmacokinetics; Food Effect; Proton Pump; GED-0301; Mongersen

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics - Cmax

  Maximum observed concentration in plasma

  Up to Day 17

• Pharmacokinetics -AUC0-∞

  Estimation of AUC from time zero extrapolated to infinity

  Up to Day 17

Secondary Outcomes (1)

• Adverse Event (AE)

  Up to Day 22

Study Arms (4)

Treatment A = single oral dose GED 0301, fasted

EXPERIMENTAL

Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast

Drug: GED-0301

Treatment B = single oral dose GED 0301, fed

EXPERIMENTAL

Subjects will receive a single oral 160 mg dose of GED-0301 after a 10 hour overnight fast, and within 30 minutes of completely consuming a high fat meal.

Drug: GED-0301

Treatment C = single oral dose GED 0301 fasted

EXPERIMENTAL

Subjects will receive an oral dose of 160 mg of GED-0301 given as 4 tablets of 40 mg, after a 10 hour overnight fast

Drug: GED-0301

Treatment D = oral omeprazole and GED-0301

EXPERIMENTAL

Subjects will receive one oral dose of 40 mg omeprazole once a day for 6 days. On the 5th day, a single oral 160 mg dose of GED-0301 will be given together with omeprazole.

Drug: GED-0301; Drug: Omeprazole

Interventions

GED-0301 DRUG

Also known as: Mongersen

Treatment A = single oral dose GED 0301, fasted; Treatment B = single oral dose GED 0301, fed; Treatment C = single oral dose GED 0301 fasted; Treatment D = oral omeprazole and GED-0301

Omeprazole DRUG

Treatment D = oral omeprazole and GED-0301

Eligibility Criteria

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

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is male, or non-pregnant and non-nursing female ≥ 18 and ≤ 65 years of age the time of signing the ICF.
• Subject must understand and voluntarily sign an ICF prior to any study related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• 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.
• Female subjects NOT of childbearing potential must:
• 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).
• 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.
• 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.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
• Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.
• Subject vitals are as follows:

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• 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.
• 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.
• Subject has any condition that confounds the ability to interpret data from the study.
• 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).
• Subject has used any prescription drugs or over-the-counter medication (including multi-vitamins) in the 14 days prior to the planned admission day.
• \. Subject has consumed herbal remedies or dietary supplements containing St. John's Wort, in the three weeks before the planned admission day.
• \. Subject has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• \. Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• \. 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.
• \. 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).
• \. 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.
• \. Subject smokes \> 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
• \. Subject is part of the clinical staff personnel or a family member of the clinical site staff.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Richmond Pharmacology, Ltd.

Croydon, Surrey, CR7 7YE, United Kingdom

Location

MeSH Terms

Interventions

GED0301; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Maria Palminsano, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

GB (1)