A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants

Completed · Phase 1

Conditions studied: Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs), Healthy Participants

In brief

This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both parts of the study. Part 1 of the study is to investigate the pharmacokinetics (PK) of the selumetinib granule compared to the PK of selumetinib capsule, when administered with water under the fasted conditions. Part 2 of the study is to investigate the PK of selumetinib granule and capsule under fed conditions. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration.

Key facts

Study ID

NCT03649165

Run by

AstraZeneca

People needed

24

Starts

2018-09-05

Expected to finish

2018-10-21

Last updated by the study team

2018-11-08

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent before any study-specific procedures.
• Healthy male participants aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
• Participants is able to consume a low-fat meal within a 30-minute period.
• Participants has a creatinine clearance (CRCL) greater than 50 mL/min using Cockcroft-Gault formula.
• Participants is willing to comply with contraception requirements as described below:
• Male participants with sexual partners who can become pregnant (i.e., women of childbearing potential) must use 2 highly-effective methods of contraception, one of which must be a barrier method (condom with spermicide) from the time of the first administration of the IMP until 12 weeks after the last administration of the IMP to avoid pregnancy and/or potential adverse effects on the developing embryo.
• Participants with sexual partners who are pregnant must use an effective method of contraception (barrier method) from the time of the first administration of the IMP until 12 weeks after the last administration of the IMP.
• Participants must avoid sperm donation during the study and for 12 weeks after the last administration of the IMP.
• Reliable methods of contraception must be used consistently and correctly.
• Reliable methods of contraception for participants include: Use of barrier methods (condom and spermicide) for the duration of the study until 12 weeks after the last administration of the IMP.
• Acceptable methods for participants partners include:
• Use of implants, injectables and combined oral contraceptives (must be used in combination with a barrier method of contraception)
• Use of intrauterine devices (must be used in combination with a barrier method of contraception)

You may not qualify if…

• Participants of Japanese, non-Japanese Asian or Indian ethnicity.
• Participants has any one parent or grandparent (maternal or paternal) that was Japanese or non-Japanese Asian (e.g., China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia) or Indian.
• History or presence of central serous retinopathy or retinal vein thrombosis, IOP greater than 21 mmHg or uncontrolled glaucoma.
• History of any clinically significant disease or disorder which, in the opinion of the PI, may put the participant at risk because of participation in the study, influence the result of the study or influence the participants ability to participate in the study.
• Participant has ophthalmologic conditions as follows:
• Current or past history of central serous retinopathy/retinal pigment epithelial detachment or retinal vein occlusion.
• Intra-ocular pressure > 21 mmHg or uncontrolled glaucoma (irrespective of IOP).
• Participant has any cardiac conditions as follows:
• Uncontrolled hypertension (BP ≥ 150/95 mmHg despite medical therapy).
• Acute coronary syndrome within 6 months before starting treatment.
• Uncontrolled Angina - Canadian Cardiovascular Society grade II-IV despite medical therapy.
• Symptomatic heart failure New York Heart Association (NYHA) Class II-IV, prior or current cardiomyopathy, or severe valvular heart disease.
• Prior or current cardiomyopathy including but not limited to the following: 1) Known hypertrophic cardiomyopathy.
• Known arrhythmogenic right ventricular cardiomyopathy. 3) Previous moderate or severe impairment of LVEF < 45% on echocardiography even if full recovery has occurred.
• Left ventricular ejection fraction below the lower limit of normal (LLN) or < 55% measured by ECHO at the Screening Visit.
• Severe valvular heart disease.
• Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on ECG at rest.
• QTcF > 450 ms or other factors that increase the risk of QT prolongation.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
• Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at the Screening Visit, which in the opinion of the PI, may put the participant at risk because of his participation in the study. Test may be repeated twice at the discretion of the Investigator if abnormal.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• A suspected/manifested infection according to the International Air Transport Association (IATA) Categories A and B infectious substances.
• History of, or current alcohol or drug abuse, as judged by the principal investigator (PI).
• Participation in another clinical study (investigational product administered within 30 days before the Screening Visit, or participation in a method development study [no drug] 30 days before the Screening Visit). Participation is defined as the completion of a treatment related visit.
• Planned in-patient surgery, dental procedure or hospitalization during the study.

Where it is running

• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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