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Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

Information source: Mylan Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: MYL-1402O (Drug); US marketed Avastin(R) (Drug); EU marketed Avastin(R) (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Mylan Inc.

Official(s) and/or principal investigator(s):
Matthew A. Hummel, PhD, Study Director, Affiliation: Mylan Pharmaceuitcals Inc.

Summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Clinical Details

Official title: A Single Center, Randomized, Double-blind, 3-arm Parallel Phase1 Study to Assess PK, Safety, and Tolerability of a Single 90 Min iv Infusion of 1 mg/kg MYL-1402O, EU Avastin®, and US Avastin® in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Area under the plasma concentration versus time curve (AUC) for bevacizumab.

Secondary outcome: Peak Plasma Concentration (Cmax) of bevacizumab

Detailed description: Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i. v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i. v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i. v. infusion of EU marketed Avastin® (1 mg/kg).

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Males aged 18-55 yrs. (inclusive)

- BMI: 19. 0 to 30. 0 kg/m2 (inclusive)

- Weight: ≥ 60kg and ≤100kg

- Subjects should be willing to use adequate contraception and not donate sperm from

admission to clinical research center until 6 months post dosing.

- All intermittent medications should have be stopped at least 14days prior to

admission to the clinical research center.

- All intermittent non topical medication must be stopped at least 30days prior to

admission to the clinical research center.

- Ability and willingness to abstain from ETOH 48hrs prior to admission to the clinical

research center.

- Medical history without significant findings per the PI

- Resting supine systolic BP of ≤140mmHg and diastolic BP of ≤90mmHg

- ECGs (via 12 lead) showing NCS findings per PI

- All clinical laboratory tests of blood and urine, WNL and/or without clinically

significant findings

- Willing/able to sign ICF

- Normal bowel habits

- Negative medical history regarding fecal blood positivity

- Normal and/or NCS spot protein/creatinine (PCR) ratio.

Exclusion Criteria:

- Previous participation in the current study

- History of prior exposure to bevacizumab

- Evidence of clinically significant findings

- Cognitive and / or mentally impaired handicaps that would affect ability to make an

informed consent and/or remain compliant to the requirements of this trial.

- History of relevant drug and/or food related allergies.

- History of or known hypersensitivity to bevacizumab or other recombinant human or

humanized antibodies or inactive ingredients.

- Tobacco product use w/I 1 yr. prior to drug administration.

- History of ETOH and or drug abuse/addiction

- Positive urine drug and ETOH screen for opiates, methadone, cocaine, amphetamines

including XTC, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and ETOH.

- Average intake of more than 24 units of ETOH / wk. (1 unit of ETOH equals ~250mL of

beer, 100mL of wine or 35mL of spirits).

- Consumption of any foods containing poppy seeds w/I 48 hrs. prior to screening and

admission to the clinical research center

- Positive screen for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV)

antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.

- Participation in a drug study w/I 60days or 5 half-lives of the previous drug.

- Participation in more than 3 other drug studies in the 10months prior to drug

administration in the current protocol.

- Donation or loss of more than 100mL of blood w/I 60days prior to drug administration.

Donation or loss of more than 1. 5liters of blood w/I the 10months prior to drug administration.

- Strenuous exercise w/I 96 hrs. Prior to admission to the clinical research center.

- Significant or acute illness w/I 5days prior to drug administration that may impact

safety assessments per the judgement of the PI.

- Unsuitable veins for infusion and/or venepuncture

- Surgery including surgery with suturing via a dental procedure or would dehiscence

w/I 28days of dosing. Any planned surgery or dental procedures during the study and for at least 30days after follow up.

- Presence of a non-healing wound or fracture.

- History of bleeding disorders

- History of thromboembolic conditions

- History of gastrointestinal perforations or any fistulae.

- History of orthostatic hypotension, fainting spells, blackouts for any reasons.

- History of hypertension

- Medically significant dental disease or dental neglect with signs and or symptoms of

local or systemic infection that would likely require a dental procedure during the course of study.

Locations and Contacts

PRA Health Sciences - Early Development Services, Zuidlaren 9471 GP, Netherlands
Additional Information

Starting date: April 2015
Last updated: August 7, 2015

Page last updated: August 20, 2015

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