A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
Brief Summary

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.

Overall Status Completed
Start Date June 2014
Completion Date November 2014
Primary Completion Date November 2014
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Area under the semaglutide plasma concentration−time curve During a dosing interval (0-24 hours) at steady state
Secondary Outcome
Measure Time Frame
Maximum observed semaglutide plasma concentration During a dosing interval (0-24 hours) at steady state
Number of treatment emergent adverse events (TEAEs) recorded From the time of first dosing (Day 1) until completion of the follow-up visit (Days 119−126)
Enrollment 48
Condition
Intervention

Intervention Type: Drug

Intervention Name: semaglutide

Description: Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.

Arm Group Label: Semaglutide

Intervention Type: Drug

Intervention Name: placebo

Description: Once-daily oral administration as tablets.

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Healthy male Japanese and Caucasian subjects

- Age between 20 and 55 years (both inclusive) at time of signing informed consent

- Body weight of above or equal to 54.0 kg

- Body mass index (BMI) between 20.0 and 25.0 kg/m^2 (both inclusive)

- Glycosylated haemoglobin A1c (HbA1c) below or equal to 6.0%

Exclusion Criteria:

- Presence or history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, GI (gastrointestinal), endocrine, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders, as judged by the investigator. Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)

- History of chronic pancreatitis or idiopathic acute pancreatitis

- Smoking of more than 5 cigarettes (including nicotine substitute products), or the equivalent, per day or unwilling to refrain from smoking whenever required for the trial procedure

- Use of prescription drugs within 3 weeks or 5 times the half-life, whichever is longer, prior to Visit 2 (Day 1), non-prescription drugs within 1 week prior to Visit 2 (Day 1). The use of vitamins and minerals, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

- Any blood drawn in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

- Previous GI surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder (e.g., cholecystectomy), pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic and gastric endoscopy

Gender: Male

Minimum Age: 20 Years

Maximum Age: 55 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility:
Location Countries

Japan

Verification Date

December 2014

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Semaglutide

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov