A Three Stage, Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Teriparatide.

It had 13 arms (groups): Teriparatide group 1 (active comparator), excipients (placebo comparator), API (experimental), API optimization 1 (experimental) and API optimization 2 (experimental).

Subcutaneous injection of Teriparatide.

Oral pill without API.

Oral administration of pill with API.

The registry classes the interventions as drug.

More on the Plan

This study will have three stages.

Who Took Part

Enrollment: 42 actual participants took part.

It was open to people of any sex 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. Male and female volunteers ,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 10 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

Design: randomized, crossover and triple-blind.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Teriparatide and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-07 with completion listed for 2013-08.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Adverse events (time frame: up to 17 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Teriparatide in 42 people.

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.