Clinical trial NCT02287779: Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Multiple Oral Doses of SHP626 in Overweight and Obese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Alcoholic Steatohepatitis
Lead sponsor: Mirum Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.


Eligibility criteria: Inclusion Criteria:

* Males that comply with any applicable contraceptive requirements or females of non-childbearing potential
* No history of active or chronic disease other than that allowed by study (hypertension, hyperlipidemia and GERD or heartburn)
* Has a body mass index of 25-35 kg/m2 with a body weight of greater than 140lbs (assessed at screening)

Exclusion Criteria:

* No history of alcohol or substance abuse, including use of tobacco
* No substantial changes in eating habits or exercise routine.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study
timeFrame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Secondary outcomes:
measure: Average Total Fecal Bile Acid (FBA) Concentration
timeFrame: Day -2 up to Day 14
measure: Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration
timeFrame: Day -1 to Day 15
measure: Number of Participants With Stool Hardness Using Bristol Stool Chart
timeFrame: Day -2 to Day 14
measure: Maximum Observed Plasma Concentration (Cmax) of Volixibat
timeFrame: Day 1 to Day 14
measure: Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)
timeFrame: Day 1 to Day 14
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
Study officials:
affiliation: Mirum
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Palmer M, Jennings L, Silberg DG, Bliss C, Martin P. A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis. BMC Pharmacol Toxicol. 2018 Mar 16;19(1):10. doi: 10.1186/s40360-018-0200-y.