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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02146079 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3634Other idU1111-1147-6660Other idJapicCTI-142550
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
44 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
21 May 2014
Primary completion
20 Oct 2014
Completion
20 Oct 2014
First posted
23 May 2014 (estimated)
Last update posted
18 Apr 2018
Conditions
Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

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

    NCT02146079

    21 May 2014 to 20 Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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), and the safety and tolerability of semaglutide in healthy male Japanese and Caucasian subjects.

Interventions

  • semaglutideDrug
  • placeboDrug

Arms4

  • Experimental

    Semaglutide 0.5 mg

    Dose-escalation trial

  • Placebo comparator

    Semaglutide placebo 0.5 mg

  • Experimental

    Semaglutide 1.0 mg

    Dose-escalation trial

  • Placebo comparator

    Semaglutide placebo 1.0 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the plasma semaglutide concentration-time curve

    Time frame · During a dosing interval (0-168 hours) at steady state

Secondary outcomes(3)

  1. Maximum observed plasma semaglutide concentration at steady state

    Time frame · 0-168 hours after the last dose of semaglutide (0.5 and 1.0 mg)

  2. Change in body weight from baseline to the end of treatment

    Time frame · Day 1 of Visit 2 (2-21 days after Visit 1), Day 92

  3. Number of treatment emergent adverse events (TEAEs) from baseline to follow-up

    Time frame · From Day 1 of Visit 2 (2-21 days after Visit 1) to Day 120-127 (Visit 23)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

10 results

A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Ikushima et al. 2018Advances in therapycited by 25

PMID 29536338PMC5910468DOI 10.1007/s12325-018-0677-1PUB-29536338

Free to read · publisher termsCC BY-NC10 results
Read at sourceSee results (10)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 20 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy male Japanese and Caucasian subjects * Age between 20 and 55 years (both inclusive) at the time of signing informed consent * Body weight of equal to or above 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% * For Japanese subjects only: both parents Japanese * For Caucasian subjects only: both parents Caucasian Exclusion Criteria: * Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiological, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2) * History of chronic pancreatitis or idiopathic acute pancreatitis * Calcitonin above or equal to 50 ng/L * History of alcohol abuse within 1 year from screening, or a positive result in the alcohol breath test, or consumption of more than 21 units of alcohol weekly: 1 unit of alcohol equals approximately 250 mL of beer or lager, or approximately120 mL (one glass) of wine or Japanese sake, or approximately 20 mL of spirits * 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 (randomisation), non-prescription drugs within 1 week prior to Visit 2 (randomisation). The use of vitamins, minerals and nutritional supplements, and the occasional use of paracetamol (acetaminophen) or acetylsalicylic acid are permitted

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