AZD8108 SAD/MAD in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | September 2015 |
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of AZD8108 in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled study of single and multiple
ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day
screening period, an in-house period during which AZD8108 or placebo will be administered
orally as a solution, and a 4- to 10-day follow-up period after discharge.
ascending dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day
screening period, an in-house period during which AZD8108 or placebo will be administered
orally as a solution, and a 4- to 10-day follow-up period after discharge.
In Part 1 of the study (single ascending dose portion), approximately 32 subjects will be
randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts
(AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108
and 2 subjects will be randomized to receive placebo. Each subject will receive only one
dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose
portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be
randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be
randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each
subject will receive twelve doses of either AZD8108 or placebo
randomly assigned. Eight (8) subjects will be randomized in each of 4 dosage-level cohorts
(AZD8108 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD8108
and 2 subjects will be randomized to receive placebo. Each subject will receive only one
dose of either AZD8108 or placebo on Day 1. In Part 2 of the study (multiple ascending dose
portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be
randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be
randomized to receive AZD8108 and 2 subjects will be randomized to receive placebo. Each
subject will receive twelve doses of either AZD8108 or placebo
Inclusion Criteria: Inclusion Criteria: 1. Subjects must understand the nature of the
study and must provide signed and dated written informed consent in accordance with local
regulations before the conduct of any study-specific procedures. 2. Men and postmenopausal
or surgically sterile women age 18-55 years inclusive. 3. Subjects must have a body mass
index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
4.Subjects must be fluent in English.
Exclusion Criteria:1. A history or presence of a clinically significant hepatic, renal,
gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic,
dermatologic, or neurologic abnormality. 2. A clinically significant abnormality on
physical examination, neurological examination, EEG, ECG, vital signs or laboratory
evaluations at screen or between screen and dose administration. 3. A history of seizure.
4.A history of head trauma, including closed head injury with loss of consciousness. 5.Any
history of suicide attempt or suicidal behavior, or, in the opinion of the investigator,
clinically significant risk of suicide or violent behavior. 6. Urine drug screen positive
for a drug of abuse 7. A family history of schizophrenia, schizoaffective disorder, or
psychosis in first degree relatives.
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