A new treatment for malaria by an old drug (Griseofulvin).

Pharmacokinetic evaluation of Griseofulvin in healthy volunteers.

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000307707

Acronym

GT-BSPC

Enrollment

Registered

2013-03-20

Start date

2013-04-01

Completion date

Unknown

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

Griseofulvin inhibits ferrochelatase (FECH). Inhibition of FECH in the red cell prevents the growth of malarial parasites. We plan a trial using griseofulvin to treat volunteers infected with malaria. This current proposed trial is a pharmacokinetics trial with two different regimen of griseofulvin, 500mg bd or a one-off bolus of 2g. The concentration of griseofulvin in red cells will be measured daily as will the ability of malarial parasites to infect cells taken from griseofulvin-treated volunteers. Haematological and clinical biochemical parameters will be followed.

Interventions

This is a trial to test two regimen of griseofulvin administration. Each of the two regimen will be performed on different volunteers. This is done in healthy volunteers. Blood will be used to measure griseofulvin levels in red cells and to measure haematological and clinical biochemical parameters. Blood will also be used to test infection rate using malarial parasites (In vitro). The first regimen a unique (once-off) dose of 2g griseofulvin. The second regimen is 500mg griseofulvin twice

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Never had malaria

Exclusion criteria

Female, planning to have children within 6 months, liver disease, co-morbidity

Outcome results