Safety Study of Two Oral Formulations of MGCD265 Administered in Healthy Subjects in the Fasting State

NCT01930006 | Completed Phase 1

• 1 other identifier: 265-106
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

In this study two MGCD265 oral formulations at dose level of 100 mg are administered to healthy male and female subjects under fasting conditions.

Conditions

Advanced Malignancies

Keywords

c-Met; VEGFR; Ron; Cancer; Tumor; Safety; Phase 1

Outcome Measures

Primary Outcomes (1)

• To assess the bioavailability of two MGCD265 formulations.

  To compare the rate and extent of absorption of two MGCD265 oral formulations at dose level of 100 mg administered as 1 x 100 mg oral dose (Formulation A) and 2 x 50 mg oral dose (Formulation B) under fasting conditions.

  Two months

Study Arms (1)

MGCD265

EXPERIMENTAL

Drug: MGCD265

Interventions

MGCD265 DRUG

MGCD265

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects ≥18 to ≤55 years of age who are willing and able to provide informed consent prior to performing any study related procedures
• Females of childbearing potential who are using a stable contraceptive method at least 30 days prior to screening and who are willing to use one of the following acceptable birth control methods until 30 days after the last dose of study drug:
• Abstinence
• Hormonal contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) for at least 3 months prior to the first dose of the study drug and male condom and intravaginal spermicide
• Intra-uterine contraceptive device (IUD) in place for at least 3 months prior to the first dose of study drug plus spermicide and male condom
• Male condom and diaphragm plus spermicide;
• Male condom and cervical cap plus spermicide;
• Surgical sterilization of the partner(s) (vasectomy for 6 months minimum prior to the first dose of study drug)
• Female subjects will be considered of non childbearing potential and eligible if one of the following condition is met:
• Amenorrhea for at least 1 year, with confirmation by a follicle-stimulating hormone (FSH ≥ 40 mIU/mL)
• Hysterectomy
• Bilateral oophorectomy
• Bilateral tubal ligation
• Male subjects must agree to be abstinent or use the following acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 3 months after the last dose of study drug:
• Male condom and intravaginal spermicide plus hormonal contraceptives (birth control pills, injectable/ implantable/ insertable hormonal birth control products, transdermal patch) in use for at least 3 months

You may not qualify if:

• Females who are pregnant or are breast feeding
• History of significant hypersensitivity reaction to any substance or drug
• Clinically relevant history or evidence of significant gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the investigator would jeopardize the safety of the subject or impact validity of study results
• Clinically significant vital signs in the opinion of the investigator at screening or prior to study drug administration
• History of clinically significant cardiovascular illness including but not confined to: angina pectoris or myocardial infarction, coronary or peripheral artery bypass graft, congestive heart failure, or clinically significant cardiac arrhythmia in the opinion of the investigator
• History of clinically significant thrombotic or hemorrhagic events (including but not confined to stroke and transient ischemic attacks); history of bleeding diathesis or coagulopathy; history or presence of gastrointestinal or other conditions with risk of perforation; presence of a non-healing wound, ulcer or fracture in the opinion of the investigator
• Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTcF \> 450 msec) at screening or the pre-dose ECG or other clinically significant ECG abnormalities in the opinion of the investigator
• History of regular alcohol consumption exceed 7 drinks for females and 14 drinks per week for males within 6 months of screening or a positive alcohol breath test at screening and prior to study drug administration
• History of significant drug abuse within one year prior to screening
• Any clinically significant illness or surgery in the previous 30 days before day 1 of this study
• Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin and St John's Wort), in the previous 30 days before day 1 of this study
• Use of any drugs known to induce or inhibit hepatic metabolism (inducers such as rifampin, barbiturates, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitors such as antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluroquinolones, antihistamines) in the previous 30 days before day 1 of the study
• Use of any other prescription medications in the previous 14 days before day 1 of this study
• Use of any over-the-counter (OTC) products including cold preparations, multivitamins and dietary supplements used for therapeutic benefits and antacid preparations in the previous 7 days before day 1 of this study
• Use of Acetylsalicylic Acid (ASA) or NSAIDs (or any product containing ASA or NSAIDs) in the previous 7 days before day 1 of this study

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (1)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (1)