Clinical trial NCT05468164: A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
Conditions: Healthy
Summary: The main purpose of this study is to assess the effect of food on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it after a high-fat meal, and the effect of a change in gastric pH after multiple doses of omeprazole on how fast selpercatinib gets into the bloodstream and how long it takes the body to remove it when administered under fasted and fed conditions in healthy participants. The study will also evaluate the safety and tolerability of selpercatinib in healthy participants. The study will last up to 33 days excluding the screening period.
Interventions:
description: Administered orally
name: Selpercatinib
other_name: LOXO-292
LY3527723
type: Drug
description: Administered orally
name: Omeprazole
type: Drug
Study arms:
design_group_description: Participants received:<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state.<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state.<br/>Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
design_group_title: Treatment Sequence 1: ABCD
design_group_type: Experimental
design_group_description: Participants received:<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fasted state.<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fed state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state.<br/>Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
design_group_title: Treatment Sequence 2: ABDC
design_group_type: Experimental
design_group_description: Participants received:<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state.<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fasted state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fed state.<br/>Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
design_group_title: Treatment Sequence 3: BACD
design_group_type: Experimental
design_group_description: Participants received:<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 1 in fed state.<br/>* Single oral dose of 160 mg selpercatinib administered on Day 1 of Period 2 in fasted state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 3 in fed state.<br/>* Multiple daily oral doses of 40 mg omeprazole administered on Day 1 to Day 7 along with single oral dose of 160 mg selpercatinib on Day 1 of Period 4 in fasted state.<br/>Periods 1 and 2, 2 and 3 were separated by a 7-day washout period. There was no washout between Periods 3 and 4.
design_group_title: Treatment Sequence 4: BADC
design_group_type: Experimental
Sponsor: Eli Lilly & Co.
Collaborators: Loxo Oncology, Inc.
Drug name mappings:
name: 塞普替尼
lang: CN
name: Selpercatinib
lang: EN
name: セルペルカチニブ
lang: JP
name: 奥美拉唑
lang: CN
name: Omeprazole
lang: EN
name: オメプラゾール
lang: JP