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Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers

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ClinicalTrials.gov Identifier: NCT01931761
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose [14C] selumetinib in volunteers

Condition or disease Intervention/treatment Phase
Solid Tumours Drug: [C14] selumetinib (oral) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-Selumetinib in Healthy Male Volunteers
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: [C14] selumetinib 75mg single dose
[C14] selumetinib 75mg single dose
Drug: [C14] selumetinib (oral)
Single oral administration [C14] 75mg
Other Name: Selumetinib




Primary Outcome Measures :
  1. Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days ]

Secondary Outcome Measures :
  1. Metabolite profiling and identification in plasma and excreta [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ]
  2. Pharmacokinetic parameters of selumetinib [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ]
    Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR

  3. Plasma concentrations of selumetinib [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days ]
  4. Safety [ Time Frame: Assessments prior to treatment and after treatment including follow up. ]
    Adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis, physical examination, left ventricular ejection fraction, and opthalmology assessments.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures.
  • Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
  • Regular bowel movements (ie, on average production of at least 1 stool per day).

Exclusion Criteria:

  • Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
  • Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
  • History or presence of any clinically significant disease or disorder in the opinion of the investigator
  • Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931761


Locations
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United Kingdom
Research Site
Ruddington, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Stuart Mair, MD University of Aberdeen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01931761    
Other Study ID Numbers: D1532C00077
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015
Keywords provided by AstraZeneca:
Pharmacokinetics, mass balance, AZD6244