NCT02248818

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2014

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2017

Completed
Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

September 23, 2014

Results QC Date

August 17, 2016

Last Update Submit

March 9, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

  • Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal

    Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal

    Day -1 to 7 days after last dose

  • Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108

    Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108

    Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose

  • Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108

    Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 6

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose

  • Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108

    Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 12

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose

  • Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108

    Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 \& 7, Cohort 6 dod not reach Day 12

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose

  • Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108

    Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose

  • Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108

    Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 6

    Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose

  • Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108

    Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 12

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose

Secondary Outcomes (5)

  • Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose

  • Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108

    Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose

  • Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108

    Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose

  • Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108

    Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose

  • Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD

    Day 12 compared to Day 1

Other Outcomes (3)

  • EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction

    8 hours after dose

  • EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction

    8 hours after dose

  • EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction

    8 hours after dose

Study Arms (2)

AZD8108

EXPERIMENTAL

Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 6 subjects will receive AZD8108

Drug: AZD8108

Placebo to match AZD8108

PLACEBO COMPARATOR

Subjects will participate in 1 of 7 groups and receive single or multiple doses of AZD8108 or matching placebo. In each group 2 subjects will receive matching placebo

Drug: Placebo

Interventions

AZD8108DRUG

Drug: AZD8108 Single or Multiple doses administered orally as a solution.

AZD8108
PlaceboDRUG

Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Placebo to match AZD8108

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Limitations and Caveats

Conversion of AZD8108 to active moiety AZD6567 was rapid, concentrations of AZD8108 were almost all below the level of quantification, no PK parameters were calculable for AZD8108 concentrations.

Results Point of Contact

Title
Joel Posner MD
Organization
AstraZeneca LP
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Mina Pastagia, MD, MS

    Clinilabs, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 25, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

April 7, 2017

Results First Posted

January 27, 2017

Record last verified: 2017-03

Locations

US(1)