Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal Healthy Volunteers

A single site, open label study to evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy adult volunteers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000098538

Enrollment

Registered

2015-02-04

Start date

2015-01-16

Completion date

2015-01-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy volunteers.

Interventions

Single dose study where each participant receives one dose of anatabine citrate on one occasion. The dosage will be either 3 or 4 mg oral tablet based on body weight taken with 240 ml water. If the subject weighs less than or equal to 81.4 kg the dose given will be 3 mg. If the subject weighs 81.5 kg or above they will receive 4 mg. The intervention for this trial is the test formulation of anatabine citrate. All subjects will receive their dosage and blood samples will be collected immediately prior to dosing and then one hour after dosing via venipuncture. Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Males or females In good general health Aged between 18-65 years of age inclusive Weighing between 45 and 100 kg Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator Normal ECG

Exclusion criteria

Current users of tobacco (cigarettes or smokeless) Current user of anatabine citrate dietary supplements Allergy to any of the product ingredients Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk Participation in any drug or medical device study within 30 days of entering this study

Outcome results