NCT02016911|CompletedPhase 1

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9924-40822013-000550-21U1111-1139-1272

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredDec 2013

StartedDec 2013

CompletionJan 2015

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1 diabetes

Timeline

Completed

Started Dec 2013

Longer than P75 for phase_1 diabetes

Geographic Reach

3 countries

6 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

December 12, 2013

Completed

Same day until next milestone

Study Start

First participant enrolled

December 12, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2015

Completed

Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.1 years

First QC Date

December 12, 2013

Last Update Submit

May 9, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2 Healthy

Outcome Measures

Primary Outcomes (1)

Area under the semaglutide plasma concentration curve
From time 0 to 24 hours after the 10th dosing

Secondary Outcomes (3)

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
Maximum observed SNAC plasma concentration
0 to 24 hours after the 10th dosing

Study Arms (2)

Subjects with hepatic impairment

EXPERIMENTAL

Drug: semaglutide

Subjects with normal hepatic function

ACTIVE COMPARATOR

Drug: semaglutide

Interventions

semaglutideDRUG

Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg

Subjects with hepatic impairmentSubjects with normal hepatic function

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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)

Contact the study team to confirm eligibility.