An evaluative study to assess the safety of Nanocelle (Trademark) Atorvastatin Formulation Administered Oro-buccally (by mouth spray) in Healthy Adult Volunteers.

A Phase 0, Multi-dose, Open-label, Clinical Trial To Investigate The Safety of a Micro-dose of a Nanocelle (Trademark) Atorvastatin Formulation Administered Oro-buccally in Healthy Adult Volunteers

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001285549

Enrollment

Registered

2015-11-25

Start date

2015-11-30

Completion date

2015-12-14

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

This clinical trial aims to explore the safety and tolerability of Atorvastatin Oro-buccal Spray Micelle. Who is it for? All participants who are aged 18 years or over with no allergic reactions to statins

Interventions

The clinical study will investigate the tolerability and safety of Nanocelle Atorvastatin. The patient will be instructed to initially administer oro-buccally 0.01 mg of atorvastatin per spray once a day. Administration of additional sprays will be a maximum of 1 spray over 24 hours for a total of 7 days.. Schedule Dose: Day 1: Administer 1 spray oro-buccally 5 minutes prior to P.K collection, a maximum dose of 0.01mg/day. Schedule Dose: Days 2–7: Administer 1 spray once a day [maximum day 1–

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 80 Years

Healthy volunteers

Yes

Inclusion criteria

1) Participants greater than or equal 18 years of age up to and including 80 years ago at time of entry on study 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 3) Participants agree to undergo venepuncture on multiple occasions 4) Participants agree to adhere to the study protocol 5) Hyperlipidaemic 6) Normal ECG reading QTcF < 450 msec 7) No history of statins reaction

Exclusion criteria

1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs 2) Previous history of rhabdomyolysis 3) Alcohol abuse 4) The use of any illicit drugs 5) Pregnancy or nursing an infant 6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant 7) Elevated liver enzymes 2x normal limits

Outcome results