Acromegaly Nutritional, Metabolic, Endocrine Acromegaly and pituitary gigantism
Conditions
Interventions
Eligible subjects will be invited to attend the study unit to undergo screening procedures 28 days before checking into the study unit, which includes:
1. Giving informed consent to participate in the
Sponsors
Glide Pharmaceutical Technologies Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoint: Ratio of geometric means (test product and reference product) and their 90% confidence intervals (CIs) for plasma AUC0–t, and Cmax of octreotide, calculated based on blood samples taken at 0, 15, 20, 30, 45, 60 and 90 minutes, and 2, 4, 6, 8, 10, 12 hours post dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints: 1. Treatment emergent AEs, recorded if reported from time of signed consent to completion of the last study-related procedure 2. Vital signs, recorded pre-dose, 60 minutes, 2 hours, 12 hours post dose in each treatment period 3. Physical examination (including ear, nose, throat, cardiovascular system, pulmonary system, skin, abdomen, neurological system and body weight), recorded on day 1, day 3 and post study 4. Twelve-lead ECG, recorded pre-dose, 12 hours post dose in each treatment period 5. Safety laboratory evaluations (clinical chemistry, haematology and urinalysis) Pharmacokinetic parameters of test and reference products: 1. Median difference in tmax of octreotide and its 90% CI 2. AUC0–8 3. t1/2/Kel These will be assessed or measured at 0, 15, 20, 30, 45, 60 and 90 minutes, and 2, 4, 6, 8, 10, 12 hours post dosing Subject tolerance assessment of drug delivery system: 1. Tolerability: question subject and visually examine injection sites 2. Pain: subjects indicate injection-site pain by use of a 100mm visual analogue scale, with no pain on the left and worst possible pain on the right border Exploratory endpoint(s): Subject feedback on the drug delivery systems, using questionnaire at the end of the treatment period | — |
Countries
United Kingdom
Outcome results
None listed