Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers

Healthy Clinical Trial

Official title:

Phase I Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02117245
• Other study ID #: 265-105
• Status: Completed
• Phase: N/A
• First received: May 7, 2012
• Last updated: January 6, 2015
• Start date: December 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2015
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

The objective of this study is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.

Description:

The study objective is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female volunteer

2. Volunteer age of 40 to 65 years

3. Females of childbearing potential using a stable contraceptive method at least 14 days prior to screening and willing to use acceptable birth control methods from 7 days prior to first dose until 30 days after last dose of study drug:

4. Female volunteers will be considered of non childbearing potential and eligible if:

• Amenorrhea for at least 1 year;

• Hysterectomy;

• Bilateral oophorectomy at least 6 weeks prior to first dose;

• Bilateral tubal ligation at least 6 months prior to first dose;

• Hysteroscopic sterilization.

5. Male volunteers who agree to be abstinent or use acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 90 days after the last dose of study drug:

• Male volunteers who also agree to not donate sperm from the time of taking the first dose until 90 days after the last dose.

6. Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2

7. Non- or ex smokers for at least 6 months.

8. Availability for the entire study period

9. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements

10. Clinical laboratory values within the laboratory's stated normal range; or they must be without any clinical significance

11. Have no clinically significant diseases captured in medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations

12. Willingness to adhere to protocol requirements

The informed consent form must be signed by all volunteers, prior to participation in the study.

Exclusion Criteria:

1. Females who are pregnant or are lactating

2. History of significant hypersensitivity reactions to any substance or drug

3. History or presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs

4. Seated blood pressure higher than and equal to 140/90 mmHg at screening

5. Seated blood pressure higher than and equal to 140/90 mmHg before drug administration

6. History or predisposition to cardiovascular illness

7. History or predisposition to thrombotic or hemorrhagic events, bleeding diathesis or coagulopathy, gastrointestinal or other conditions with risk of perforation, presence of a non-healing wound, ulcer or fracture

8. Presence of significant pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease

9. No major surgery within 28 days prior to first dose

10. Suicidal tendency, disposition to seizures, state of confusion, clinically relevant psychiatric diseases

11. Presence of out-of-range cardiac interval or ECG abnormalities

12. Maintenance therapy with any drug, or history of drug dependency or alcohol abuse

13. Any clinically significant illness in the previous 28 days before day 1 of study

14. Use of any enzyme-modifying drugs in the previous 28 days before day 1 of study

15. Use of any drugs known to induce or inhibit hepatic metabolism in the previous 28 days before day 1 of study

16. Any history of tuberculosis and/or prophylaxis for tuberculosis

17. Positive urine screening of ethanol and/or drugs of abuse

18. Positive results to HIV, HBsAg or anti-Hepatitis C Virus tests

19. Females who are pregnant

20. Volunteers who took an Investigational Product or donated 50 mL or more of blood in the previous 28 days before day 1 of this study

21. Donation of 500 mL or more of blood in the previous 56 days before day 1 of this study

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Canada	Algorithme	Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma concentration (Cmax) of MGCD265.	Bioavailability of study drug under fed conditions compared to fasting conditions in healthy male and female volunteers.	26 days	No