NCT02016911CompletedPhase 1
Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide (NNC0113-0217) in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Area under the semaglutide plasma concentration curve
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject with normal hepatic function or hepatic impairment (mild, moderate or severe)
- •Body mass index (BMI) 18.5-40.0 kg/m^2 (both inclusive)
Exclusion Criteria
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
- •History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
- •Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- •History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
Arms & Interventions
Subjects with hepatic impairment
Experimental
Intervention: semaglutide (Drug)
Subjects with normal hepatic function
Active Comparator
Intervention: semaglutide (Drug)
Outcomes
Primary Outcomes
Area under the semaglutide plasma concentration curve
Time Frame: From time 0 to 24 hours after the 10th dosing
Secondary Outcomes
- Maximum observed SNAC plasma concentration(0 to 24 hours after the 10th dosing)
- Maximum observed semaglutide plasma concentration(0 to 24 hours after the 10th dosing)
- Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve(From time 0 to 24 hours after the 10th dosing)
Investigators
Study Sites (1)
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