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

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01930006

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies	Drug: MGCD265	Phase 1

Detailed Description

The objective of this study is to compare the rate and extent of absorption of two MGCD265 oral formulations at a dose level of 100 mg administered to healthy male and female subjects under fasting conditions.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1 Single Dose 2-Way Crossover Comparative Bioavailability Study Of Two Oral Formulations Of MGCD265 In Healthy Male And Female Subjects - Fasting State

Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MGCD265	Drug: MGCD265

Arm

Intervention/Treatment

Experimental: MGCD265

Drug: MGCD265

Outcome Measures

Primary Outcome Measures

To assess the bioavailability of two MGCD265 formulations. [Two months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
Male condom and IUD in place for at least 3 months plus spermicide;
Male condom and diaphragm plus spermicide
Male condom and cervical cap plus spermicide
Vasectomy for 6 months minimum prior to the first dose of study drug

Male subjects also agree to not donate sperm from the time of taking the first dose of study drug until 3 months after the last dose of study drug

Subject with a body mass index (BMI) of 18.0 to 32.0 kg/m2 at screening
Subject is a current non-smoker and has not used any nicotine containing product within 3 months prior to screening
Subjects who are considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results and screening ECG as judged by the investigator
Subjects who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, pharmacokinetic sampling schedule and other study procedures

Exclusion Criteria:

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
Use of MAO inhibitors within 30 days of day 1 of the study
Positive urine drug screen or urine cotinine test at screening and prior to study drug administration
Positive results to HIV, HBsAg or anti-HCV tests at screening
Subjects who took an Investigational Product (in another clinical trial) in the previous 30 days (90 days for biologics) before day 1 of this study
Donation of plasma within 7 days prior to dosing. Any donation/loss of blood or blood products within 3 months of the screening visit
Prior exposure to MGCD265