A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects

Registration

Registration

NCT02920385

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

45

Start

2016-10-10

Primary completion

2017-04-26

Lead sponsor

Novo Nordisk A/S

Conditions

Diabetes; Healthy

Interventions

DRUG:Semaglutide; DRUG:SNAC; DRUG:Levothyroxine; DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

EUDRACT_NUMBER:2015-005558-36; OTHER:U1111-1177-2807; NIH:2015

Registered primary outcomes

• Baseline-corrected area under the total T4 serum concentration-time curve from 0 to 48 hours after a single dose of levothyroxine [On day 1 (levothyroxine administered alone), on day 38 (levothyroxine co-administered with SNAC) and on day 89 (levothyroxine co-administered with oral semaglutide)]
• Area under the semaglutide plasma concentration-time curve during a dosing interval (0-24 hours) at steady state [On day 88 (oral semaglutide administered alone) and on day 139 (oral semaglutide co-administered with placebo tablets)]