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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 5, 2018

Primary Completion Date

October 21, 2018

Study Completion Date

October 21, 2018

Conditions
Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)Healthy Participants
Interventions
DRUG

Treatment A

During Part 1 of the study, participants will receive single doses of selumetinib 25 mg granule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.

DRUG

Treatment B

During Part 1 of the study, participants will receive single doses of selumetinib 50 mg capsule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.

DRUG

Treatment C

During Part 2 of the study, participants will receive single doses of selumetinib 25 mg granule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.

DRUG

Treatment D

During Part 2 of the study, participants will receive single doses of selumetinib 50 mg capsule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.

DRUG

Acetaminophen

Participants will receive a single 500mg dose of acetaminophen at the same time.

Trial Locations (1)

21225

Research Site, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY