Nasally and sc Administered Teriparatide in Healthy Volunteers

NCT01913834 | Unknown Phase 1

• 2 other identifiers: 13MP002Grant Ref: EP/K502364/1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Parathyroid hormone 1-34

Outcome Measures

Primary Outcomes (2)

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

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

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

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

Secondary Outcomes (1)

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

  up to 1 year

Study Arms (5)

Forsteo

ACTIVE COMPARATOR

Synthetic PTH 1-34 Single dose Subcutaneous administration 20.0 micrograms

Drug: Forsteo

CP046 PTH CriticalSorb 22.5 R

EXPERIMENTAL

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

Drug: CP046 PTH CriticalSorb

CP046 PTH CriticalSorb 45.0 R

EXPERIMENTAL

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

Drug: CP046 PTH CriticalSorb

CP046 PTH CriticalSorb 90.0 R

EXPERIMENTAL

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

Drug: CP046 PTH CriticalSorb

CP046 PTH CriticalSorb 90.0 O

EXPERIMENTAL

Synthetic PTH 1-34 Single dose Nasal administration 90 micrograms

Drug: CP046 PTH CriticalSorb

Interventions

Forsteo DRUG

Subcutaneous administration 20 micrograms

Also known as: teriparatide

Forsteo

CP046 PTH CriticalSorb DRUG

Comparison of different doses of drug and nasal delivery devices

Also known as: teriparatide

CP046 PTH CriticalSorb 22.5 R; CP046 PTH CriticalSorb 45.0 R; CP046 PTH CriticalSorb 90.0 O; CP046 PTH CriticalSorb 90.0 R

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tahir Masud, MRCP, FRCP

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tahir Masud, MRCP, FRCP

CONTACT

tahir.masud@nuh.nhs.uk

Richard Pearson, PhD

CONTACT

richard.pearson@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: August 1, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 1, 2013

Record last verified: 2013-07

Locations

GB (1)