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A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects
Plain-language guide to NCT02571140: phase 1 non-randomized trial of Teriparatide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02571140
- Phase
- phase 1
- Status
- completed
- Start
- 2013-10
- Completion (planned or actual)
- 2017-08
- Participants
- 30 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Drug Safety and Bioavailability
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Teriparatide.
This study will have one stage consisting of multiple treatment visits.
It had two arms (groups): Active Comparator (active comparator) and Oral PTH (1-34) (experimental).
Subcutaneous injection of Teriparatide.
Oral administration of pill with API with different optimizations.
The registry classes the interventions as drug.
Who Took Part
30 actual participants took part.
It was open to men only aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Signed Informed consent to the study. Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive,. Subjects able to adhere to the visit schedule and protocol requirements. Negative serology to HIV, Hepatitis B, Hepatitis C. No known drug and alcohol abuse.
The full record lists 15 inclusion and 9 exclusion criteria; among the exclusions: active infections; history of drug or alcohol abuse; known allergies or sensitivities to components of study treatment or study procedures, including soy.
How the Study Was Run
The set-up was non-randomized, crossover and open-label.
In the crossover set-up each of the participants took both Teriparatide and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Teriparatide study: the participants and staff both knew the treatment.
It started in 2013-10 with completion listed for 2017-08.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Peak Plasma Concentration (time frame: 60-522 days).
It also tracked 1 secondary outcome, for example Adverse Events.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Teriparatide in 30 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Teriparatide compound page, all human trials.
Our Notes on the Compound
Teriparatide: A parathyroid hormone fragment, PTH(1-34), with human trials and approved-pen labeling; the research vial is not the approved pen.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.