Status:
COMPLETED
Injection Site Pain Comparison of Excipient Solutions
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain...
Eligibility Criteria
Inclusion
- Male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent.
- Body Mass Index (BMI) equal to or above 25.0 and below 30.0 kg/m\^2.
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the Investigator.
Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant within 1 week of Day 2 or is of childbearing potential and not using highly effective contraceptive methods.
- Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Glycated haemoglobin (HbA1c) equal to or above 6.5 % (48 mmol/mol) at screening.
- Use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to Trial Product administration), within 14 days prior to Day 1.
- Average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
- Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre.
- Use of tobacco and nicotine products, defined as any of the below:
- Smoking more than 1 cigarette or the equivalent per day on average.
- Not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period.
- Subject is not able to understand and read English or Dutch, or subject is not able to understand and comply with the trial requirements.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2020
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04482725
Start Date
July 20 2020
End Date
September 25 2020
Last Update
October 19 2021
Active Locations (1)
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1
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NZ