HealthyPhase 1NCT01340183

Clinical Study Assessing the Safety, Tolerability, and Pharmacokinetics of Intravenous AZD5099 in Healthy Subjects

A Phase 1 study testing AZD5099 in people with Healthy, run by AstraZeneca at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: AZD5099
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: May 2011to Dec 2011
Phase: Phase 1
Are there results?: None posted in the registry

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

Who may be able to join

Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling
Healthy male and female (with nonchildbearing potential) volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels within the laboratory-defined post-menopausal range
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until at least 3 months after dosing with the investigational product
Have a body mass index (BMI) between 18 and 30.5 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive

Who cannot join

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms >3 times a week, or blood in stool in previous 6 months not related to anal trauma
For male volunteers any history of sexual dysfunction or impotence as judged by the Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Glendale, California

Other trials in United States

About this study

Official title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics in Intravenous AZD5099 After Single Ascending Doses in Healthy Male and Female Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of the drug AZD5099 after intravenous administration of single doses in healthy volunteers. The results from this study will form the basis for decisions regarding the future development of AZD5099 as a novel antibiotic for the treatment of serious infections in humans.

Conditions: Healthy
Being tested: AZD5099, Placebo
Keywords: Phase I, safety, tolerability, pharmacokinetics, AZD5099, volunteers, safety of the drug AZD5099, blood and urine levels of AZD5099, single intravenous doses, healthy volunteers

What participants receive

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

AZD5099Drug
IV Dose
PlaceboDrug
IV Dose

Study groups in NCT01340183
Study group	Role	What they receive
AZD5099	Experimental	IV Dose Receives: Drug: AZD5099
Placebo	Placebo comparator	IV Dose Receives: Drug: Placebo

What is being measured

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

To assess the safety and tolerability of AZD5099
To assess the safety and tolerability of AZD5099 by documenting: 1) the incidence and severity of adverse events, 2) abnormalities and time matched comparison from Day -1 to Day 1 of core body temperature and vital sign assessments, 3) electrocardiograms (ECGs), 4) telemetry, 5) clinical laboratory assessments, 6) physical examinations, and 7) withdrawals.
Measured: Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge).

Secondary outcomes (28)

Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: Pre-dose
Blood samples to characterize the pharmacokinetics of AZD5099, 15 min
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 15 minutes post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 30 min
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 30 minutes post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 1 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 2 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 2.5 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 2.5 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 3 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 3 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 4 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 4 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 5 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 5 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 6 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 6 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 8 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 8 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 10 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 10 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 12 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 12 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 24 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 24 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 36 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 36 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 48 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 72 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 72 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 96 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 96 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 120 hour
Blood samples will be taken to characterize the pharmacokinetics of AZD5099 by determination of Cmax, tmax, λz, AUC, AUC(0-t), t½λz, Vz, Vdss, and CL.
Measured: 120 hour post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, pre-dose
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between -12 to 0 hours
Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 0 - 4 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 4-8 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 4 - 8 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 8-12 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 8 - 12 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 12-24 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 12 - 24 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 24-48 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 24 - 48 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 48-72 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 48 - 72 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 72-96 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 72 - 96 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 96-120 hours
Urine samples to characterize the pharmacokinetics of AZD5099 by determination of the cumulative amount of unchanged drug excreted in urine [Ae(0-t)], and fraction of dose excreted into urine [fe(0-t)].
Measured: Between 96 - 120 hours post start of infusion

Timeline

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

May 2011Dec 2011

First posted22 Apr 2011 (estimated)
Study startMay 2011
Primary completionDec 2011 (estimated)
Study completionDec 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340183
Sponsor's protocol ID: D0910C00015
Status last verified: Nov 2011
First submitted: 20 Apr 2011
Last updated: 1 Dec 2011
Results posted: No

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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics in Intravenous AZD5099 After Single Ascending Doses in Healthy Male and Female Subjects
ClinicalTrials.gov ID: NCT01340183
Acronym / sponsor ID: D0910C00015
Conditions: Healthy
Keywords: Phase I, safety, tolerability, pharmacokinetics, AZD5099, volunteers, safety of the drug AZD5099, blood and urine levels of AZD5099
Phase: Phase 1
Study type: Interventional
Recruitment status: Suspended
Enrolment: 80 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Dec 2011 (estimated)
Study completion: Dec 2011 (estimated)
First posted: 22 Apr 2011 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
AZD5099	Experimental	Drug: AZD5099IV Dose
Placebo	Placebo comparator	Drug: PlaceboIV Dose

Who may qualify

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

Key inclusion criteria (7 listed)

Provision of signed and dated, written informed consent prior to any study-specific procedures including the genetic sampling
Healthy male and female (with nonchildbearing potential) volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) levels within the laboratory-defined post-menopausal range
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation

Key exclusion criteria (5 listed)

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
History of gastrointestinal ulcer disease, inflammatory bowel disease, indigestion symptoms >3 times a week, or blood in stool in previous 6 months not related to anal trauma
For male volunteers any history of sexual dysfunction or impotence as judged by the Investigator

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
AZD5099IV Dose	Drug	AZD5099
PlaceboIV Dose	Drug	Placebo

Primary outcome

To assess the safety and tolerability of AZD5099
Time frame: Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge).
To assess the safety and tolerability of AZD5099 by documenting: 1) the incidence and severity of adverse events, 2) abnormalities and time matched comparison from Day -1 to Day 1 of core body temperature and vital sign assessments, 3) electrocardiograms (ECGs), 4) telemetry, 5) clinical laboratory assessments, 6) physical examinations, and 7) withdrawals.

28 secondary outcomes

Blood samples to characterize the pharmacokinetics of AZD5099, pre-dose
Time frame: Pre-dose
Blood samples to characterize the pharmacokinetics of AZD5099, 15 min
Time frame: 15 minutes post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 30 min
Time frame: 30 minutes post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 1 hour
Time frame: 1 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 2 hour
Time frame: 2 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 2.5 hour
Time frame: 2.5 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 3 hour
Time frame: 3 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 4 hour
Time frame: 4 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 5 hour
Time frame: 5 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 6 hour
Time frame: 6 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 8 hour
Time frame: 8 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 10 hour
Time frame: 10 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 12 hour
Time frame: 12 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 24 hour
Time frame: 24 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 36 hour
Time frame: 36 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 48 hour
Time frame: 48 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 72 hour
Time frame: 72 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 96 hour
Time frame: 96 hour post start of infusion
Blood samples to characterize the pharmacokinetics of AZD5099, 120 hour
Time frame: 120 hour post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, pre-dose
Time frame: Between -12 to 0 hours
Urine samples to characterize the pharmacokinetics of AZD5099, 0-4 hours
Time frame: Between 0 - 4 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 4-8 hours
Time frame: Between 4 - 8 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 8-12 hours
Time frame: Between 8 - 12 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 12-24 hours
Time frame: Between 12 - 24 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 24-48 hours
Time frame: Between 24 - 48 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 48-72 hours
Time frame: Between 48 - 72 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 72-96 hours
Time frame: Between 72 - 96 hours post start of infusion
Urine samples to characterize the pharmacokinetics of AZD5099, 96-120 hours
Time frame: Between 96 - 120 hours post start of infusion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.

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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.

Mark Yen, MD principal investigator

Parexel

David Melnick study director

AstraZeneca

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 AZD5099 in people with Healthy, 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?

The sponsor lists 7 inclusion and 5 exclusion criteria. 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: paused, as of the sponsor's last update on 1 Dec 2011. 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?

Results are not available in the source record.

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?

To assess the safety and tolerability of AZD5099 (time frame: Ongoing throughout the study from consent (up to 28 days prior to dosing) through withdrawal or completion (up to 10 days after discharge).). 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 NCT01340183.

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 1 Dec 2011.