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 |
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| 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. |
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| Overall Status | Completed | ||||||
| Start Date | June 2014 | ||||||
| Completion Date | November 2014 | ||||||
| Primary Completion Date | November 2014 | ||||||
| Phase | Phase 1 | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| 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 |
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| 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 |
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| Overall Official |
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| Location |
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| Location Countries |
Japan |
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| Verification Date |
December 2014 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: Semaglutide Type: Experimental Label: Placebo Type: Placebo Comparator |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Double (Participant, Investigator) |
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