A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese

What Was Tested

This registered phase 1 trial tested L-Carnitine.

It had 1 arm (groups): Single arm (experimental).

The registry classes the interventions as drug.

More on the Plan

Subject need to follow blood, urine collection and diet control as required by protocol before the day of run-in period.

During the trial should avoid vigorous exercise, meanwhile to avoid long-time bedding.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 19 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Gender: male and female, healthy subjects;. Age: 19 to 45 years of age, of similar age;. Blood pressure: SBP 90-139mmHg, DBP 60-89 mmHg;. The subjects must be informed consent before the trial, and voluntarily signed a written informed consent form;. Subjects can be good communication with researchers and to complete the test in accordance with program requirements.

The full record lists 6 inclusion and 41 exclusion criteria; among the exclusions: hepatitis b surface antigen test positive;; hepatitis c antibody test positive;; AIDS, syphilis testing positive;.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the L-Carnitine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-06 with completion listed for 2015-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under Curve (AUC) (time frame: 0h, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after administration).

It also tracked 1 secondary outcome, for example cumulative excretion percentage.

What This Means in Plain Language

Put simply, this is a phase 1 trial of L-Carnitine in 16 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 L-Carnitine compound page, all human trials.