Healthy VolunteersPhase 1AZD8108NCT02248818

AZD8108 SAD/MAD in Healthy Volunteers

A Phase 1 study testing AZD8108 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: AZD8108
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 258 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinilabs, Inc.
New York, New York, 10019

Other trials in United States

About this study

Official title: 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

Read the detailed description

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

Conditions: Healthy Volunteers
Being tested: AZD8108, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD8108Drug
Drug: AZD8108 Single or Multiple doses administered orally as a solution.
PlaceboDrug
Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution

Study groups in NCT02248818
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108
Measured: 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
Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)
Measured: 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
Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 \& 7, Cohort 6 did not reach day 12
Measured: 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
Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 \& 7, Cohort 6 did not reach day 12
Measured: 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
Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 \& 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]
Measured: Day 12 compared to Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Sep 2015

First posted25 Sep 2014 (estimated)
Study startNov 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02248818
Sponsor's protocol ID: D5800C00001
Acronym: AZD8108
Status last verified: Mar 2017
First submitted: 23 Sep 2014
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02248818
Acronym / sponsor ID: AZD8108 / D5800C00001
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 258 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 27 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AZD8108	Experimental	Drug: AZD8108Subjects 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
Placebo to match AZD8108	Placebo comparator	Drug: PlaceboSubjects 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD8108Drug: AZD8108 Single or Multiple doses administered orally as a solution.	Drug	AZD8108
PlaceboPlacebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution	Drug	Placebo to match AZD8108

Primary outcome

Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal
Time frame: Day -1 to 7 days after last dose
Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal
Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108
Time frame: 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 infinity), AZD6765 after single/first dose of AZD8108
Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108
Time frame: 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 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108
Time frame: 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 infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 \& 7, Cohort 6 did not reach Day 12
Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108
Time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose
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
Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108
Time frame: 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 single/first dose of AZD8108
Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108
Time frame: 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 6 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 6
Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108
Time frame: 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 : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 \& 7, Cohort 6 did not reach Day 12

5 secondary outcomes

Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 12 compared to Day 1

Results and safety

Results posted to the registry on 27 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD8108 20 mg SAD	0	0
AZD8108 60 mg SAD	0	0
AZD8108 95 mg SAD	0	0
Placebo SAD	0	0
AZD8108 50 mg	0	0
AZD8108 90 mg MAD (6)	0	0
AZD8108 90 mg MAD (7)	0	0
Placebo MAD	0	0
Screen	155	48

Primary outcome: Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal

Time frame: Day -1 to 7 days after last dose. Number. Unit: Participants

Measure	AZD8108 20 mg SAD n = 6	AZD8108 60 mg SAD n = 6	AZD8108 95 mg SAD n = 6	Placebo SAD n = 6	AZD8108 50 mg MAD n = 6	AZD8108 90 mg MAD (6) n = 8	AZD8108 90 mg MAD (7) n = 6	Placebo MAD n = 4
Value	2	3	0	0	4	3	0	0

Population analysed: Safety population

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

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	AZD8108 20 mg SAD n = 6	AZD8108 60 mg SAD n = 6	AZD8108 95 mg SAD n = 6	Placebo SAD n = 0	AZD8108 50 mg MAD n = 6	AZD8108 90 mg MAD (6) n = 8	AZD8108 90 mg MAD (7) n = 6	Placebo MAD n = 0
Value	726 (22.4)	2651 (17.1)	4533 (11.3)	–	2160 (37.8)	4318 (13.2)	4597 (21.8)	–

Population analysed: Pharmacokinetic Population (those dosed with AZD8108)

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

Time frame: Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	AZD8108 20 mg SAD n = 0	AZD8108 60 mg SAD n = 0	AZD8108 95 mg SAD n = 0	Placebo SAD n = 0	AZD8108 50 mg MAD n = 6	AZD8108 90 mg MAD (6) n = 0	AZD8108 90 mg MAD (7) n = 6	Placebo MAD n = 0
Value	–	–	–	–	2061 (34.7)	–	4408 (26.3)	–

Population analysed: Pharmacokinetic Population (those dosed with AZD8108)

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

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	AZD8108 20 mg SAD n = 0	AZD8108 60 mg SAD n = 0	AZD8108 95 mg SAD n = 0	Placebo SAD n = 0	AZD8108 50 mg MAD n = 6	AZD8108 90 mg MAD (6) n = 0	AZD8108 90 mg MAD (7) n = 6	Placebo MAD n = 0
Value	–	–	–	–	2837 (47.6)	–	6733 (30.2)	–

Population analysed: Pharmacokinetic Population (those dosed with AZD8108)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAD cohorts 2 weeks, MAD cohorts up to 1 month. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD8108 20 mg SAD	0 of 6 (0%)	6 of 6 (100%)	Not reported
AZD8108 60 mg SAD	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
AZD8108 95 mg SAD	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Placebo SAD	0 of 6 (0%)	3 of 6 (50%)	Not reported
AZD8108 50 mg MAD	0 of 6 (0%)	3 of 6 (50%)	Not reported
AZD8108 90 mg MAD (6)	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
AZD8108 90 mg MAD (7)	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Placebo MAD	0 of 4 (0%)	3 of 4 (75%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mina Pastagia, MD, MS principal investigator

Clinilabs, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD8108 in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal (time frame: Day -1 to 7 days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02248818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.