ISRCTN42727091Active, not recruitingPhase 2
Dissecting the Contribution of glucocorticoid metabolism in Mild Autonomous Cortisol Secretion: a randomised controlled trial of the 11ß-HSD1 inhibitor SPI-62
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Participant is willing and able to give informed consent for participation in the trial
- •2. Aged 18 years or above
- •3. 09.00 h serum cortisol >51 nmol/L after overnight dexamethasone (1 mg) within the last 6 months performed in the absence (for at least 4 weeks prior to testing) of concomitant estrogen-containing medication.
- •4. Adrenal adenoma(s) that has (have) not been surgically removed, and with benign characteristics on cross-sectional imaging.
- •5. Body mass index 18 to 45 kg/m2
- •6. Stable dose of current regular antihypertensive and/or glucose-lowering medication for at least 12 weeks prior to trial entry.
- •7. Female participants of childbearing potential and male participants whose partner is of childbearing potential must be willing to ensure that they and their partner use effective contraception during the trial and for 90 days thereafter.
- •8. In the Investigator’s opinion, the participant is able and willing to comply with all trial requirements.
- •9. Participant is willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial
Exclusion Criteria
- •1. Female participant is pregnant, lactating, or planning pregnancy during the course of the trial
- •2. Scheduled elective surgery or other procedures requiring general anaesthesia are required during the course of the trial
- •3. Participants with a life expectancy of less than 6 months
- •4. A diagnosis of idiopathic thrombocytopenic purpura or any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •5. A clinical phenotype consistent with classical Cushing’s syndrome (e.g. thin skin, easy bruising, proximal myopathy)
- •6. Evidence from medical records of elevated aldosterone/renin ratio (above local reference range) on blood sampling
- •7. Renal impairment indicated by eGFR <60 ml/min/1.73 m², calculated using an appropriate and validated equation
- •8. Participants with a diagnosis of liver cirrhosis or liver function test (LFT) elevations that exceed 1.5 x the upper limit of normal at screening and require further clinical investigation: LFT pattern consistent with Gilbert’s syndrome is allowed
- •9. Recent (< 1 year) myocardial infarction or stroke, orthostatic or vasovagal syncope
- •10. QT interval corrected (QTc) interval >500 ms, uncorrected QT interval >600 ms, or evidence of significant, life-threatening arrhythmia or bradycardia (heart rate <45 bpm) according to electrocardiogram (ECG)
- •11. Anaemia, defined as haemoglobin =110 g/L (female) and =130 g/L (male)
- •12. Untreated hypothyroidism
- •13. Taking a prohibited medication or exposure to a prohibited medication (section 10.6)
- •14. Current evidence or significant past history of alcohol misuse disorder (> 35 units per week female and >50 units per week male, or other indicators of possible alcohol misuse) in the opinion of the Investigator
- •15. Uncontrolled hypertension (>160/100 mmHg)
- •16. Type 1 diabetes or Type 2 diabetes requiring medication (with the exception of metformin monotherapy)
- •17. Recent (within the last 3 months) or planned night-shift work during the duration of the study
- •18. Contraindication to any of the study treatments or known or suspected hypersensitivity ?to the investigational product, compounds of the same class, other study treatments or any excipients
- •19. Participation in an interventional study in which involvement was completed less than 12 weeks before recruitment into the current study
- •20. Administration of any vaccine within 4 weeks prior to randomization or planned during the trial
- •21. SARS-CoV-2 infection within 4 weeks, or hospitalization for COVID-19 disease within 6 months, prior to randomization
- •22. Any major surgery within 1 month prior to randomization or planned during the trial
Investigators
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