A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.

NCT02238782 | Completed Phase 1 Results

• 1 other identifier: D1532C00080
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the absolute bioavailability of oral selumetinib in healthy male volunteers

Conditions

Healthy Volunteers Bioavailability Study

Keywords

bioavailability; pharmacokinetics; I phase; AZD6244; cancer

Outcome Measures

Primary Outcomes (1)

• Absolute Bioavailability

  To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)\*100

  0 to 72 hours post-dose

Study Arms (1)

selumetinib 75mg single dose

EXPERIMENTAL

3 capsules of 25 mg administered orally

Drug: selumetinib 75mg single dose; Other: [14C] selumetinib IV solution

Interventions

selumetinib 75mg single dose DRUG

3 capsules of 25 mg given as a single dose

Also known as: Selumetinib

selumetinib 75mg single dose

[14C] selumetinib IV solution OTHER

single, radiolabeled, IV (infused), microdose (80 μg) of \[14C\] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose

selumetinib 75mg single dose

Eligibility Criteria

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

You may qualify if:

• Provision of written informed consent
• Healthy male volunteers aged 18 to 65
• Male volunteers with sexual partners who are pregnant or who could become pregnant should use two highly effective methods of contraception (including one barrier method) for at least 14 days after completing the study and should avoid sperm donation for 14 days after study completion.
• Body mass index between 18 and 30 kg/m2 and weighing between 50 and 100 kg.
• Use no nicotine containing products for at least 3 months prior to screening with a negative cotinine screen at screening and Day 1 (Visit 2)
• Calculated creatinine clearance greater than 50 mL/min using Cockcroft Gault formula.

You may not qualify if:

• Involvement in the planning and/or conduct of the study
• Previous enrolment for treatment in the present study
• Japanese or non Japanese Asian or Indian ethnicity.
• Any one parent or grandparent is Japanese or non-Japanese Asian or Indian.
• Treatment with another new chemical entity or participation in any other clinical study that included drug treatment within at least 3 months
• Participation in another clinical study involving administration of \[14C\] radioactivity within 1 year.
• Current or past history of central serious retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
• Any clinically significant disease or disorder which, may put the volunteer at risk because of participation in the study, influence the study result or influence the volunteer's ability to participate in the study.
• Any clinically relevant abnormal findings in physical examination, haematology, clinical chemistry, urinalysis, vital signs or 12 lead ECG at Visit 1, which may put the volunteer at risk because of his participation in the study.
• Use of drugs with enzyme inducing properties such as St John's Wort within 4 weeks prior to the administration of the investigational product
• Use of any other prescribed medicine and over the counter drugs within 2 week or 5 times the half life, whichever is longer prior to the administration of the investigational product up to and including the follow up visit (Visit 4), with the exception of occasional use of paracetamol or ibuprofen and over the counter adrenergic nasal spray. No medications known to prolong the QT/corrected QT interval are allowed.
• Excessive intake of caffeine containing drinks or food
• Any intake of grapefruit and Seville oranges including products containing grapefruit or Seville oranges within 7 days of the admission on Day -1.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to Selumetinib.
• Plasma donation within 1 month of screening (Visit 1) or any blood donation or blood loss greater than 500 mL during the 3 months prior to screening (Visit 1).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AZD 6244

Results Point of Contact

• Title: Gabriella Mariani
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

+44 7818 523 899

Study Officials

• Stuart Mair

  Quotient Clinical Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 12, 2014
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Locations

GB (1)