WHO ICTRP trial
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of…
ACTRN12612000176864 · Australian New Zealand Clinical Trials Registry (ANZCTR) · Recruiting
Key facts
| Trial ID | ACTRN12612000176864 |
|---|---|
| Public title | A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis C Genotype 1 Infection. |
| Scientific title | A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis… |
| Primary sponsor | CPR Pharma Services |
| Registry | Australian New Zealand Clinical Trials Registry (ANZCTR) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | Australia;New Zealand;Romania;France;Moldova, Republic Of |
| Conditions | Chronic Hepatitis C infection; Chronic Hepatitis C infection;Infection - Other infectious diseases;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon |
| Interventions | Part 1: Healthy Volunteers will receive one of 5 single ascending doses (SAD) of ALS-002158 ranging from 50 mg to 750 mg. ALS-002158 or placebo is administered orally via a syringe. Subjects in Part 1 and subjects in Part 3 will receive… |
| Registration date | Aug 2, 2012 |
| Target size | 78 |
| Secondary IDs | Nil |
| Registry page | anzctr.org.au |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: