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
A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects
Sponsors
Source
Novo Nordisk A/S
Oversight Info
Has Dmc
No
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
2014-06-01
Completion Date
2014-11-01
Primary Completion Date
2014-11-01
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
Conditions
Intervention
Intervention Type
Drug
Intervention Name
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
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 |
|
Tokyo 130-0004 Japan |
Location Countries
Country
Japan
Verification Date
2014-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Secondary Id
U1111-1148-4141
JapicCTI-142572
Number Of Arms
2
Arm Group
Arm Group Label
Semaglutide
Arm Group Type
Experimental
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
June 10, 2014
Study First Submitted Qc
June 10, 2014
Study First Posted
June 11, 2014
Last Update Submitted
December 2, 2014
Last Update Submitted Qc
December 2, 2014
Last Update Posted
December 3, 2014
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.