Clinical trial NCT04482725: Injection Site Pain Comparison of Excipient Solutions
Official title: A Trial to Assess the Injection Site Pain Experience of Excipient Solutions Relevant for Subcutaneous Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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 excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Intensity of injection site pain
timeFrame: 1 min after each injection (Day 1 and Day 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosur (1452)
role: STUDY_DIRECTOR
References: