Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide

NCT02231684 | Completed Phase 1

• 3 other identifiers: NN9535-36872013-004566-34U1111-1149-3980
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of three different strengths of semaglutide and the absolute bioavailability of semaglutide.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the semaglutide plasma concentration curve

  From day 0-day 35/840 hours

Secondary Outcomes (3)

• Maximum observed semaglutide plasma concentration

  From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths

• Area under the semaglutide plasma concentration-time curve

  From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)

• Number of treatment emergent adverse events (TEAEs)

  From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)

Study Arms (8)

s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)

EXPERIMENTAL

Drug: semaglutide

i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)

EXPERIMENTAL

Drug: semaglutide

s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)

EXPERIMENTAL

Drug: semaglutide

Interventions

semaglutide DRUG

Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).

s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml); s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml); s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml); s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml); s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml); s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects (based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the investigator)
• Age between 18 and 55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 20 and 30 kg/m\^2 (both inclusive)

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1 % per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device) or sexual abstinence or vasectomised partner
• Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
• Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
• History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
• History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
• Smoking or use of any nicotine products (including nicotine patches, gum etc.) in the last 3 months prior to screening or a positive nicotine test

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berlin, 14050, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

DE (1)