safety of a new antimalarial drug in healthy, human volunteers

Phase 1 study of the safety, tolerability and pharmacokinetic of CDRI Compound 97/78, a novel antimalarial drug in normal healthy human volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002812

Enrollment

Registered

2012-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: CDRI 97/78: New antimalarial drug Dose: single ascending doses from 100 to 800mg Frequency and duration

SINGLE dose Route of administration: oral Control Intervention1: Placebo Dose, frequency, duration- single dose Route of administration:oral: to compare with the intervention

Eligibility

Inclusion criteria

Inclusion criteria: Normal routine haematology (haemoglobin, total lymphocyte count, differential count, platelet count) Normal clinical biochemistry (SGOT, SGPT, serum bilirubin, serum creatinine, blood urea, serum electrolytes, random blood sugar, total protein, serum lipid profile) Normal urine and stool analysis (routine examination and microscopy)

Exclusion criteria

Exclusion criteria: A history of having donated blood in the past 3 months, HIV or HBsAg positivity, history of any drug intake in the past 15 days, history of receiving any enzyme-inducing agent in the preceding 15 days, history of participating in any IND study in last 6 months, history of participating in any non-IND study in the past 3 months, history of allergy or hypersensitivity to any medication, history of peptic disorder, chronic smoker > 6 cigarettes/beedies per day, alcoholic (history of daily alcohol intake in last 6 months), history of any drug abuse, tobacco user in any form, history of any chronic disease and taking medication, history of taking non-allopathic drug in the past 6 months for any illness or history of any major illness in past (viz. meningitis, hepatitis, tuberculosis, epilepsy, nephritis having received treatment and presently asymptomatic).

Design outcomes

Primary

Measure	Time frame
Maximum tolerated doseTimepoint: 7 days after single dose of study drug	—

Secondary

Measure	Time frame
PharmacokineticsTimepoint: 7 days after single dose of study drug	—

Countries

India

Contacts

Public ContactSamir Malhotra

PGIMER

samirmalhotra345@yahoo.com01722755243

Outcome results