A clinical study to compare the performance of a novel solid dose injection of octreotide with a reference product

Not Applicable

Completed

• Conditions: Acromegaly; Nutritional, Metabolic, Endocrine; Acromegaly and pituitary gigantism

• Registration Number: ISRCTN72107545
• Lead Sponsor: Glide Pharmaceutical Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-12
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

1. Healthy, male subjects
2. Aged 24–45 years
3. A body mass index (defined as body mass in kilograms divided by the square of body height in metres) of 18.5–30 kg/m2
4. Willing to give written consent after reading the study information and informed consent form (ICF), and discussing the trial with the investigator or an appropriate member of the study staff
5. Judged by the investigator to be capable of understanding and complying with the requirements of the trial
6. The subject’s primary care physician has confirmed that within the 12 months before first dosing there is nothing in their medical history that would preclude their enrolment into a clinical study
7. Able to tolerate a dummy actuation from the Glide SDI device
8. Willing to give written consent to have data entered into The Over Volunteering Prevention System
9. Subjects must have type I–III grade skin according to the Fitzpatrick prototyping
scale to allow for standardisation of photographs taken during the study

Exclusion Criteria

1. Use herbal supplements for 14 days prior to dosing and be unwilling to stop these for the duration of the study
2. Have a known hypersensitivity to any of the ingredients or excipients of the study treatment
3. Have been exposed to another investigational drug within 90 days prior to start of the treatment period 1
4. Have a history of major surgical procedure within 12 weeks prior to the start of the treatment period 1 or have an
expectation of a major surgical procedure during the study
5. Have a known history of gallstones
6. Have a prior or ongoing medical condition (e.g., concomitant illness, psychiatric condition, behavioural disorder, alcoholism, drug abuse), medical history, physical examination findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results
7. History of clinically significant allergies that, in the opinion of the Investigator would contraindicate their participation
8. History of, or a reason to believe that a subject has a history of, drug or alcohol abuse within the previous 5 years and at the investigator’s discretion
9. Positive test for alcohol or drugs of abuse, including amphetamine, barbiturates, benzodiazepines, cannabis, cocaine, methadone, methamphetamine, opiates (unless this can be explained by the subject’s regular prescribed therapy), phencyclidine and tricyclic antidepressants at Screening or on Day -1 (unless this can be explained by the subject’s medication)
10. The use of any over-the-counter medicine in the week prior to drug administration, with the exception of paracetamol (acetaminophen)
11. Subjects must be none smokers or an ex-smoker for at least 9 months prior to screening
12. The subject’s General Practitioner objects to them entering the trial
13. Positive results of HBsAg, hepatitis C antibody, or human immunodeficiency virus (HIV) tests
14. Unlikely to co-operate with the requirements of the study
15. Tattoos at the site of injection
16. Eczema or any significant skin condition that, in the opinion of the investigator, would make it difficult to analyse photographs

Study & Design

• Study Type: Interventional
• Study Design: Not specified