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A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin (DEFINE)

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ClinicalTrials.gov Identifier: NCT03449251
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
University of Cambridge
AstraZeneca
MedImmune LLC
Information provided by (Responsible Party):
Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date May 18, 2018
Actual Study Start Date  ICMJE March 28, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Glucose, in mmol/l
  • Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    C-peptide, in pmol/L
  • Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    glucagon, in pg/ml
  • Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    insulin, in pmol/L
  • Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    TNF-alpha, in pg/ml
  • Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants [ Time Frame: VIsit 2 to visit 5, over a period of up to 14 weeks ]
    Glucose, in mmol/l
  • Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    C-peptide, in pmol/L
  • Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants [ Time Frame: VIsit 2 to visit 5, over a period of up to 14 weeks ]
    glucagon, , in pg/ml
  • Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    insulin, in pmol/L
  • Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    TNF-alpha, in pg/ml
  • Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin [ Time Frame: Within visit 2, over a period of up to 4 weeks ]
    Absolute flow in the infused arm, in mg/dL/min
  • Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin [ Time Frame: Within visit 2, over a period of up to 4 weeks ]
    Percentage change in the infused arm, in %
  • Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin [ Time Frame: Within visit 2, over a period of up to 4 weeks ]
    Ratio, expressed as a number (no units as this is a ratio)
  • Sub-study 2b: Change in forearm blood flow parameters in healthy participants after infusion of relaxin in the presence of L-NMMA or normal saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio; absolute flow and percentage change in the infused arm
  • Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio; expressed as a number (no units as this is a ratio)
  • Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    absolute flow in the infused arm, in mg/dL/min
  • Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    percentage change in the infused arm, In %
  • Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio; absolute flow and percentage change in the infused arm
  • Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio, expressed as a number (no units as this is a ratio)
  • Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    absolute flow in the infused arm, in mg/dL/min
  • Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    percentage change in the infused arm, In %
  • Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio, expressed as a number (no units as this is a ratio)
  • Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    absolute flow in the infused arm, in mg/dL/min
  • Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    percentage change in the infused arm, In %
  • Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin [ Time Frame: Visit 2 to Visit 4, over a period of up to 8 weeks ]
    glucose, in each of the groups, in mmol/L
  • Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin [ Time Frame: Visit 2 to Visit 4, over a period of up to 8 weeks ]
    C-peptide, in each of the groups, in pmol/L
  • Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin [ Time Frame: Visit 2 to Visit 4, over a period of up to 8 weeks ]
    glucagon, in each of the groups,in pg/ml
  • Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin [ Time Frame: Visit 2 to Visit 4, over a period of up to 8 weeks ]
    insulin, in each of the groups,in pmol/L
  • Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin [ Time Frame: Visit 2 to Visit 4, over a period of up to 8 weeks ]
    TNF-alpha, in each of the groups, in pg/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03449251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Echocardiography, in L/min
  • Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    cardiac output measured by Innocor , in L/min
  • Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by bioimpedance, in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Echocardiography, in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    cardiac output measured by Innocor , in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by bioimpedance, in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Echocardiography, in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin, after a mixed meal challenge [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    cardiac output measured by Innocor , in L/min
  • Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge [ Time Frame: VIsit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by bioimpedance, in L/min
  • Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    Glucose, in mmol/L
  • Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    C-peptide, in pmol/L
  • Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    Glucagon, in pg/ml
  • Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    Insulin, in pmol/L
  • Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge [ Time Frame: Visit 2 to visit 5, over a period of up to 14 weeks ]
    TNF alpha, in pg/ml
  • Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    Ratio,expressed as a number (no units as this is a ratio)
  • Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    absolute flow in the infused arm, in mg/dL/min
  • Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline [ Time Frame: Visit 2 to visit 3, over a period of up to 10 weeks ]
    percentage change in the infused arm, In %
  • Substudy 4: Change in cardiovascular haemodynamics after infusion of relaxin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Echocardiography, in L/min
  • Substudy 4: Change in cardiovascular haemodynamics after infusion of relaxin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by bioimpedance, in L/min
  • Substudy 4: Change in cardiovascular haemodynamics after infusion of relaxin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Innocor, in L/min
  • Substudy 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Echocardiography, in L/min
  • Substudy 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by bioimpedance, in L/min
  • Substudy 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Cardiac output measured by Innocor, in L/min
  • Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Glucose, in mmol/L
  • Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    C-peptide, in pmol/L
  • Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Glucagon, in pg/ml
  • Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    Insulin, in pmol/L
  • Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin [ Time Frame: Visit 2 to visit 4, over a period of up to 8 weeks ]
    TNF alpha, glucose homeostasis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin
Official Title  ICMJE A Series of Pilot Studies to Evaluate the Haemodynamic and Metabolic Effects of Apelin and Relaxin in Healthy Humans, Subjects With Increased Weight and Patients With Type 2 Diabetes Mellitus
Brief Summary

Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications.

Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.

Detailed Description

An extensive body of evidence demonstrates a direct association between T2DM and cardiovascular complications and mortality. Unfortunately, current therapies for diabetes have failed to be translated into improvements in cardiovascular outcomes, highlighting an urgent need to develop novel therapeutic strategies that can ultimately achieve the dual outcome of improving glycaemic control and improving cardiovascular function.

While the precise cellular mechanisms involved remain to be elucidated, we hypothesise that the apelin and relaxin pathways meet these two criteria and therefore are potential therapeutic targets in conditions of abnormal glucose metabolism and heart failure.

Apelin and relaxin are safe for parenteral use as they are naturally occurring peptide hormones, have a short half-life and will be rapidly cleared. They target endogenous receptors and post-receptor signalling, and have been used in human trials without any significant side effects reported.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Identical, colourless solution
Primary Purpose: Other
Condition  ICMJE
  • Cardiovascular Diseases
  • Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Apelin
    Apelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.
  • Drug: Relaxin
    Relaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.
    Other Name: RLX
  • Drug: Normal saline
    Vehicle
    Other Name: Saline
  • Diagnostic Test: Verapamil
    NO independent challenge agent
  • Diagnostic Test: LN Monomethyl arginine
    Basal NO synthase inhibitor
    Other Name: LNMMA
Study Arms  ICMJE
  • Experimental: Substudy 1A - Apelin
    In sub-study 1A Healthy participants will receive systemic infusions of Apelin to establish a dose range
    Intervention: Drug: Apelin
  • Experimental: Substudy 1B - Apelin/Normal Saline
    In sub-study 1B , individuals with Type 2 Diabetes and individuals with increase weight will receive systemic infusions of Apelin or Normal Saline
    Interventions:
    • Drug: Apelin
    • Drug: Normal saline
  • Experimental: Substudy 2A - Relaxin/Normal Saline
    In sub-study 2A Healthy participants will receive intra-arterial infusions of Relaxin
    Interventions:
    • Drug: Relaxin
    • Drug: Normal saline
  • Experimental: Substudy 2B - Relaxin
    In sub-study 2B Healthy participants will receive intra-arterial infusions of Relaxin followed by verapamil (on a background infusion of either LN Monomethyl Arginine or Normal Saline, to test effects on nitric oxide)
    Interventions:
    • Drug: Relaxin
    • Diagnostic Test: Verapamil
    • Diagnostic Test: LN Monomethyl arginine
  • Experimental: Substudy 3A - Relaxin with Apelin/Saline
    In sub-study 3A Healthy participants will receive intra-arterial infusions of Relaxin (background infusion apelin/Normal Saline)
    Interventions:
    • Drug: Apelin
    • Drug: Relaxin
    • Drug: Normal saline
  • Experimental: Substudy 3B - Apelin with Relaxin/Saline
    In sub-study 3B Healthy participants will receive intra-arterial infusions of Apelin (background infusion Relaxin/Normal Saline)
    Interventions:
    • Drug: Apelin
    • Drug: Relaxin
    • Drug: Normal saline
  • Experimental: Substudy 4 - Apelin and Relaxin
    In sub-study 4 Healthy participants, Individuals with Type 2 Diabetes and Individuals with increase weight will receive systemic infusions of Normal saline, Relaxin, Apelin and relaxin
    Interventions:
    • Drug: Apelin
    • Drug: Relaxin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2018)
122
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy participants

  • Have given written informed consent to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • BMI in range for studies 1 and 4: 18.5-24.9 kg/m2 with waist circumference lower than 88 centimetres (35 inches) for women or 102 cm (40 inches) for men, and/or body fat level less than 32 % for women or 25% for men
  • BMI in range for studies 2 and 3: 18.5-30.0 kg/m2 without limitations in waist circumference or body fat level

Overweight/obese participants

  • Have given written informed consent to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men

Participants with type 2 diabetes mellitus

  • Have given written informed consent to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
  • Documented diagnosis of Type 2 Diabetes Mellitus, either diet controlled or treated with oral hypoglycaemic therapy

Exclusion Criteria:

  • Hypersensitivity to any of the study drugs or excipients
  • Systemic Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
  • Known heart disease
  • Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
  • Known active malignancy
  • Known renal failure (creatinine >140µmol/L)
  • Known neurological disease
  • History of Scleroderma (Study 4 only)
  • Current pregnancy, breast feeding
  • Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
  • Use of caffeine within 24 hours of study visits
  • Current involvement in the active treatment phase of other research studies, (excluding observations/non-interventional)
  • Second or third-degree AV block, sino-atrial block, sick sinus syndrome or sinus bradycardia
  • Known HIV, hepatitis B or C
  • Needle phobia
  • Participants treated with formal anticoagulant therapy such as, but not limited to, heparin, warfarin or clopidogrel
  • Diagnosis of Type 1 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP1 agonists
  • BMI <18.5
  • Aged <18 or >70 years
  • Any other clinical reason which may preclude entry in the opinion of the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03449251
Other Study ID Numbers  ICMJE DEFINE (A094666)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE
  • University of Cambridge
  • AstraZeneca
  • MedImmune LLC
Investigators  ICMJE
Principal Investigator: Joseph Cheriyan, MBCHB, FRCP Cambridge University Hospitals NHS Foundation Trust
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP