Phase 1 human study for single dose combination of oral Alpha-ketoglutarate (5 grams and 15 grams) & Inj. Sodium Thiosulphate 12.5 grams i.v. against cyanide poisoning

Phase 1 human study for single dose combination of oral Alpha-ketoglutarate (5 grams and 15 grams) & Inj. Sodium Thiosulphate 12.5 grams i.v.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001353

Enrollment

Registered

2010-11-09

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: Oral alpha ketoglutarate (5 gm and 15 gm) alone or with intravenous sodium thiosulphate (12.5%)-single dose: Dosage &amp

AdministrationAlpha-ketoglutarate:5 gm and 15 gm to be given orally with 100 and 300 ml potable water. Inj. Sodium thiosulphate 12.5%(commercial preparation), slow intravenous administration in 10 mi

Duration of the protocol study is 1 day Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Step-1: 1. Healthy human volunteers 18 - 50 years of age with 50-70kg of body weight. 2. On no permanent treatment 3. Suffering from no permanent / recurrent / chronic disease or disability Step 2: 1. Otherwise healthy human volunteers of 25 - 60 years of age with 50-70kg of body weight, half with history of mild to moderate essential hypertension (systolic blood pressure between 140-160 mm Hg at time of test), with or without treatment.

Exclusion criteria

Exclusion criteria: 1. Volunteers who do not sign the consent form. 2. Those with any contraindication for giving AKG/STS/SNP and those who are hypotensive 3. Patients with abnormalities in the laboratory screen (SGOP or SGPT > 1.5 times upper limit of normal, alkaline phosphates > 1.2 times upper limit of normal, serum creatinine> 1.5 mg/dl) 4. Patients who have any medical condition which in the judgment the investigator may render them inappropriate for participation in the trial 5. Patients who have received any other investigational drug for the last 1 month 6. Patients with smoking history of >10 pack-years

Design outcomes

Primary

Measure	Time frame
1. To collect primary human toxicity data 2. To collect human pharmacokinetic data 3. To collect preliminary efficacy data of the combination pretreatment in reducing cyanide concentration in blood 4. To standardize analytical methods to measure its blood concentration / metabolic activity using blood/urine samples for estimating bioavailability. Timepoint: NIL	—

Secondary

Measure	Time frame
1. To evaluate the safety and tolerability of study medication 2. To evaluate the effect of treatment on general health of the volunteers 3. To evaluate the physicians and patients overall assessment of the effectiveness and tolerability of the study medication Timepoint: NIL	—

Countries

India

Contacts

Public ContactAseem Bhatnagar

Institute of Nuclear Medicine & Allied Sciences, Defence R&D Organisation, Ministry of Defence

assem_bhatnagar@indiatimes.com011-23905172

Outcome results