Phase 1
Completed N=155
AZD8108 SAD/MAD in Healthy Volunteers
Healthy Volunteers
Source: ClinicalTrials.gov NCT02248818 ↗
Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal — 2; 3; 0; 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal |
2; 3; 0; 0; 4; 3 | — |
| PRIMARY Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108 |
726; 2651; 4533; 2160; 4318; 4597 | — |
| PRIMARY Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108 |
2061; 4408 | — |
| PRIMARY Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108 |
2837; 6733 | — |
| PRIMARY Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108 |
2191; 4670 | — |
| PRIMARY Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108 |
50.1; 148; 264; 146; 287; 236 | — |
| PRIMARY Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108 |
176; 330 | — |
| PRIMARY Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108 |
197; 337 | — |
| SECONDARY Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108 |
1.75; 2.00; 2.50; 1.25; 1.28; 2.55 | — |
| SECONDARY Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108 |
48.8; 33.8; 38.8 | — |
| SECONDARY Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108 |
49.4; 30.2 | — |
| SECONDARY Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108 |
1.75; 1.80 | — |
| SECONDARY Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD |
1.30; 1.37; 1.39; 1.44 | — |
Eligibility Criteria
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.
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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.
Data sourced from ClinicalTrials.gov (NCT02248818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.