Pharmacokinetic and PHarmacodynamic Analysis and Evaluation of Teriparatide (PTH 1-34) Between Sexes

NCT04921124 | Completed Phase 3

• 1 other identifier: PHAB01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To test for a difference in the pharmacokinetics (PK) and pharmacodynamics (PD) of teriparatide (PTH 1-34), between healthy male and female volunteers matched to military recruits in training.

Conditions

Stress Fracture

Outcome Measures

Primary Outcomes (2)

• Concentration over time assessed by the area under the curve (AUC) of teriparatide (PTH (1-34)).

  Compared in men and women.

  One dose (24 hours)

• The maximum concentration (Cmax) for teriparatide (PTH 1-34).

  Compared in men and women.

  One dose (24 hours)

Secondary Outcomes (5)

• Changes in cAMP production over time following a single dose of teriparatide.

  One dose (24 hours)

• Changes in cAMP metabolism over time following a single dose of teriparatide.

  One dose (24 hours)

• The reproducibility of Concentration over time assessed by the area under the curve (AUC) of teriparatide (PTH (1-34)).

  Two doses (24 hours wash out between )

• The reproducibility of changes in cAMP production over time following a repeated dose of teriparatide.

  Two doses (24 hours wash out between )

• The reproducibility of changes in cAMP metabolism over time following a repeated dose of teriparatide.

  Two doses (24 hours wash out between )

Study Arms (1)

Treatment

EXPERIMENTAL

Teriparatide, 20 µg Subcutaneous (S/C) per day. Two doses in total.

Drug: Teriparatide

Interventions

Teriparatide DRUG

PTH(1-34) cartridge and pen device

Treatment

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have provided written informed consent to participate;
• Be able to comply with protocol;
• Be able to adequately understand written and spoken English;
• Be aged between 18 and 36 years;
• Have a BMI ≥18.5 and ≤28.0 kg/m2;
• Regularly perform a minimum of 3 sessions / week of 40 minutes or more of moderate or vigorous exercise;
• Be without any clinically significant illness (free from immune, cardiovascular or metabolic diseases and absence of medical conditions that would be a bar to joining the Army),
• Have baseline blood tests within reference range as per screening assessment table (table 1). Minor abnormalities will be assessed by the PI. Participants will still be eligible if these are felt to be of no clinical importance and this decision is documented by the PI;
• Be vitamin D replete (25(OH)D ≥50 nmol/L). Potential participants presenting with 25(OH)D \<50 nmol/L I will be offered supplementation and may be re-screened once their course of treatment is complete

You may not qualify if:

• Hypersensitivity to the active PTH or any of the excipients listed in any of the SmPCs.
• Pre-existing hypercalcaemia
• Participants with skeletal malignancies or bone metastases.
• Significant musculoskeletal injury or fracture within the last 6 months. Significance to be determined by the PI.
• Digoxin and any other concurrent therapy that, in the investigators' opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
• Pregnancy, suspected pregnancy or breastfeeding. Female participants must have a negative urine pregnancy test at screening and be willing and able to use a medically accepted method of birth control (reliable use of oral contraceptive, hormonal intrauterine device, non-hormonal intrauterine device with condom, diaphragm with condom, or condom with spermicide) from the screening visit through to the end of the experimental testing visit or declare that they are abstaining from sexual intercourse from the screening visit through the end of the experimental testing visit or are surgically sterile (have undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Less than 6 months post-partum.
• Less than 6 months post-breastfeeding.
• Severe renal impairment (eGFR \<30mLs/min/1.73m2).
• Pre-existing metabolic bone diseases including hyperparathyroidism and Paget's disease of the bone.
• Unexplained elevations of total ALP.
• Prior external beam or implant radiation therapy to the skeleton.
• Participating in a concurrent drug trial. Potential participants will be excluded if they have been in receipt of an investigational drug or biological agent within the last 4 weeks (or 5 times the half-life if this is longer) prior to study entry.

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator
• Ministry of Defence, United Kingdom: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• William Fraser, Prof

  UEA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, parallel, clinical trial in two separate groups, men and women.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 10, 2021
• Study Start: May 24, 2021
• Primary Completion: July 5, 2021
• Study Completion: July 9, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)