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Nasally and sc Administered Teriparatide in Healthy Volunteers (NINTTO)

Primary Purpose

Osteoporosis

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Forsteo

CP046 PTH CriticalSorb

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring Parathyroid hormone 1-34

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Be a postmenopausal healthy female and aged greater than 55 years of age
Be able to give voluntary informed consent and from whom written consent to participate has been obtained
Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments
Be willing to abstain from alcohol for 24 hours before each dose and until the end of each study day
Be willing to abstain from smoking for 24 hours before each dose and until the end of each study day
Be willing to avoid caffeine from midnight the evening prior to each study day

Exclusion Criteria:

Have a history of alcohol or drug abuse and failure of urine tests for drug abuse
Have had any investigational drug administered within the previous 3 months.
Failed to satisfy the investigator's assessment of fitness to participate based on a completed health screening
Have consumed alcohol or tobacco within 24 hours of start of each study day
Have consumed caffeinated drink after midnight prior to each study day
Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)
Have any presently active infectious diseases (such as influenza)
Have a known hypersensitivity to teriparatide or to any of the excipients in the formulation
Have a history of nasal disorders/problems
Have a history of allergic rhinitis
Have an increased baseline risk of osteosarcoma
Have Paget's disease
Have a history of any malignancy or radiotherapy
Have a history of diabetes
Have a history of hypercalcaemia
Are taking any forbidden medications - see Appendix 2
Inability to use both of the intranasal delivery devices
Have a condition that prohibits MRI scans
Have positive HIV or Hepatitis B or C test results or engage in a lifestyle that increases the risk of the possibility of these infections

Sites / Locations

Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

Forsteo

CP046 PTH CriticalSorb 22.5 R

CP046 PTH CriticalSorb 45.0 R

CP046 PTH CriticalSorb 90.0 R

CP046 PTH CriticalSorb 90.0 O

Arm Description

Synthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms

Synthetic PTH 1-34 Single dose Nasal administration rexam device 22.5 micrograms

Synthetic PTH 1-34 Single dose Nasal administration rexam device 45.0 micrograms

Synthetic PTH 1-34 Single dose Nasal administration rexam device 90.0 micrograms

Synthetic PTH 1-34 Single dose Nasal administration 90 micrograms

Outcomes

Primary Outcome Measures

Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration.

Peak plasma concentration (cmax) of teriparatide for six hours after each single administration.

Secondary Outcome Measures

The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy

Full Information

NCT ID

NCT01913834

First Posted

June 26, 2013

Last Updated

July 31, 2013

Sponsor

Nottingham University Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT01913834

Brief Title

Nasally and sc Administered Teriparatide in Healthy Volunteers

Acronym

NINTTO

Official Title

A Single-centre, Open-label, Five-way Crossover Study in Healthy Female Participants to Assess the Pharmacokinetics of Nasally Administered Formulations of Teriparatide Compared to a Subcutaneous Injection.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nottingham University Hospitals NHS Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Osteoporosis is a reduction in bone density that increases the risk of fractures; particularly of the spine, hip and wrist. Osteoporosis is estimated to affect 200 million women worldwide - approximately one tenth of women aged 60, one-fifth of women aged 70, two-fifths of women aged 80 and two-thirds of women aged 90. Treating osteoporosis and the associated fractures costs the NHS more than two billion pounds per annum. Teriparatide is a drug currently prescribed for some osteoporosis patients by their doctor to be taken by injection. It is currently the only drug available which promotes the deposition of new bone as opposed to preventing resorption. This is the drug treatment we will be studying in this clinical trial. The drug is of a type that cannot normally be taken as a swallowed pill. This type of drugs tends to be delivered by injection, as is currently the case for teriparatide. Injections have numerous limitations and are disliked by patients. This trial will assess how well the nasal spray devices work, how long the drug stays in the nose and also how well the drug enters the bloodstream.

Detailed Description

This study aims to look at how teriparatide spreads through the nose and into the blood stream when it is given as a liquid with a nasal delivery system called CriticalSorb™. CriticalSorb has been developed by Critical Pharmaceuticals to improve the absorption of drugs through the nose into the blood stream in the hope that it will replace injections. For part of the study a radioactive compound (routinely used in the nuclear medicine clinic for diagnosis) will be added to the formulation in order to investigate how the formulation spreads through nose after it is sprayed. The study is being carried out in postmenopausal females aged greater than 55 years of age as osteoporosis commonly affects these women. The study will involve 8 visits. The first visit will be to assess eligibility. On visit 2 the participants will receive an injection of the teriparatide. On visits 2-6 the participants will receive a nasal dose of teriparatide via nasal devices at different dose levels, blood samples will be taken to measure drug levels following dosing. For visits 5 and 6 the nasal dose will have a radioactive marker added and gamma camera imaging will also be carried out. These visits will also compare two different nasal devices. Visit 7 will be a follow up visit. There will be one further visit during the study to acquire a MRI scan of the head that will assist analysis of the scintigraphic images.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Parathyroid hormone 1-34

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Forsteo

Arm Type

Active Comparator

Arm Description

Synthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms

Arm Title

CP046 PTH CriticalSorb 22.5 R

Arm Type

Experimental

Arm Description

Synthetic PTH 1-34 Single dose Nasal administration rexam device 22.5 micrograms

Arm Title

CP046 PTH CriticalSorb 45.0 R

Arm Type

Experimental

Arm Description

Synthetic PTH 1-34 Single dose Nasal administration rexam device 45.0 micrograms

Arm Title

CP046 PTH CriticalSorb 90.0 R

Arm Type

Experimental

Arm Description

Synthetic PTH 1-34 Single dose Nasal administration rexam device 90.0 micrograms

Arm Title

CP046 PTH CriticalSorb 90.0 O

Arm Type

Experimental

Arm Description

Synthetic PTH 1-34 Single dose Nasal administration 90 micrograms

Intervention Type

Drug

Intervention Name(s)

Forsteo

Other Intervention Name(s)

teriparatide

Intervention Description

Subcutaneous administration 20 micrograms

Intervention Type

Drug

Intervention Name(s)

CP046 PTH CriticalSorb

Other Intervention Name(s)

teriparatide

Intervention Description

Comparison of different doses of drug and nasal delivery devices

Primary Outcome Measure Information:

Title

Area under the plasma concentration time curve (AUC) of teriparatide for six hours after each single administration.

Time Frame

predose, 0,1,2,3,4,6, hours post-dose

Title

Peak plasma concentration (cmax) of teriparatide for six hours after each single administration.

Time Frame

predose, 0,1,2,3,4,6 hours post-dose

Secondary Outcome Measure Information:

Title

The percentage of radiolabelled formultation deposited and cleared from the nose measured by gamma scintigraphy

Time Frame

up to 1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be a postmenopausal healthy female and aged greater than 55 years of age Be able to give voluntary informed consent and from whom written consent to participate has been obtained Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments Be willing to abstain from alcohol for 24 hours before each dose and until the end of each study day Be willing to abstain from smoking for 24 hours before each dose and until the end of each study day Be willing to avoid caffeine from midnight the evening prior to each study day Exclusion Criteria: Have a history of alcohol or drug abuse and failure of urine tests for drug abuse Have had any investigational drug administered within the previous 3 months. Failed to satisfy the investigator's assessment of fitness to participate based on a completed health screening Have consumed alcohol or tobacco within 24 hours of start of each study day Have consumed caffeinated drink after midnight prior to each study day Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv) Have any presently active infectious diseases (such as influenza) Have a known hypersensitivity to teriparatide or to any of the excipients in the formulation Have a history of nasal disorders/problems Have a history of allergic rhinitis Have an increased baseline risk of osteosarcoma Have Paget's disease Have a history of any malignancy or radiotherapy Have a history of diabetes Have a history of hypercalcaemia Are taking any forbidden medications - see Appendix 2 Inability to use both of the intranasal delivery devices Have a condition that prohibits MRI scans Have positive HIV or Hepatitis B or C test results or engage in a lifestyle that increases the risk of the possibility of these infections

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tahir Masud, MRCP, FRCP

tahir.masud@nuh.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Pearson, PhD

richard.pearson@nottingham.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tahir Masud, MRCP, FRCP

Organizational Affiliation

Nottingham University Hospitals NHS Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nottingham University Hospitals NHS Trust

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

12. IPD Sharing Statement

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