Healthy VolunteersPhase 1NCT01545583

A Study of LY3016859 in Healthy Volunteers

A Phase 1 study testing LY3016859 intravenous and LY3016859 subcutaneous in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

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

Official record

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Trial summary

The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY3016859 intravenous and LY3016859 subcutaneous
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 56 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2012to Sep 2012
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy men and women of non-childbearing potential as determined by medical history and physical examination (PE), and:
Men agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days after the final dose
Women are not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or post-menopause. Post-menopausal status will be defined as a woman 45 years of age or older with either 12 months of spontaneous amenorrhea, or 6-12 months of spontaneous amenorrhea combined with follicle stimulating hormone (FSH) greater than (>) 40 international units per liter (IU/L)
Are reliable and are willing to make themselves available for the duration of the study, and are willing to follow site specific study procedures
Must weigh greater than or equal to (≥) 50 kilograms (kg) at time of screening and dosing
Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow blood sampling as per the protocol
Must be a non-smoker

Who cannot join

Are currently enrolled in, or have discontinued within the last 60 days from a clinical trial involving an investigational drug that has not received regulatory approval for any indication, or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
Have previously completed or withdrawn from this study or any other study investigating LY3016859, and have previously received the investigational product
Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator indicates a medical problem that would preclude study participation
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or have:
Confirmed corrected QT interval using Fridericia's formula (QTcF) > 450 milliseconds (msec) for men and > 470 msec for women
Bundle branch blocks or other conduction abnormalities other than mild first-degree atrio-ventricular block

Show all 17Show fewer

Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
History of unexplained syncope
Family history of unexplained sudden death or sudden death due to long QT syndrome
T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or Hepatitis B and/or positive Hepatitis B surface antigen
Show use of any medication with potential to mask allergic response for example (e.g.) antihistamines, systemic glucocorticoids or antipyretic agents) within 3 days of dosing (Note: Acetaminophen or nonsteroidal analgesics for headache may be allowed as needed in the Investigator's judgment. The following medications are also specifically allowed in this study: vitamins at normal replacement doses, hormone replacement therapies e.g. estrogen, thyroid hormone), topical medications with limited systemic effects (e.g. eye drops, skin creams, vaginal antifungals, hemorrhoid preparations, etcetera (etc.), stable preventive therapies for hyperlipidemia and gastric acidity disorders)
Have donated blood of more than 500 milliliters (mL) within the last month.
Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol within 48 hours of entry into study and for the duration of the study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Have an abnormal blood pressure (sitting) defined as diastolic blood pressure (DBP) > 95 or less than (<) 50 millimeters of mercury (mmHg) and/or systolic blood pressure (SBP) > 150 or < 90 mmHg confirmed by at least 1 repeat measurement
Have evidence of regular use of known drugs of abuse or show positive findings for such use on urinary drug screening
Will donate blood or participate in another clinical trial within 3 months or 5 half-lives of study drug (whichever is longer) of receiving the last study drug administration

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: Study of the Safety, Tolerability and Pharmacokinetics of LY3016859 After Single Intravenous and Subcutaneous Dosing in Healthy Volunteers

The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body

Conditions: Healthy Volunteers
Being tested: LY3016859 intravenous, Placebo intravenous, LY3016859 subcutaneous, Placebo subcutaneous

What participants receive

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

LY3016859 intravenousDrug
Administered intravenously
Placebo intravenousDrug
Administered intravenously
LY3016859 subcutaneousDrug
Administered subcutaneously
Placebo subcutaneousDrug
Administered subcutaneously

Study groups in NCT01545583
Study group	Role	What they receive
Placebo intravenous	Placebo comparator	Placebo administered once intravenously Receives: Drug: Placebo intravenous
0.1 milligram (mg) LY3016859 intravenous	Experimental	0.1 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
1 mg LY3016859 intravenous	Experimental	1 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
10 mg LY3016859 intravenous	Experimental	10 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
50 mg LY3016859 intravenous	Experimental	50 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
250 mg LY3016859 intravenous	Experimental	250 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
750 mg LY3016859 intravenous	Experimental	750 mg LY3016859 administered once intravenously Receives: Drug: LY3016859 intravenous
Placebo subcutaneous	Placebo comparator	Placebo administered once subcutaneously Receives: Drug: Placebo subcutaneous
50 mg LY3016859 subcutaneous	Experimental	50 mg LY3016859 administered once subcutaneously Receives: Drug: LY3016859 subcutaneous

What is being measured

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

Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Measured: From baseline up to 8 weeks post dose

Secondary outcomes (4)

Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)
Measured: Predose up to 8 weeks post dose
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin
Measured: Predose up to 8 weeks post dose
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859
Measured: Predose up to 8 weeks post dose
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)
Measured: Predose up to 8 weeks post dose

Timeline

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

Apr 2012Sep 2012

First posted7 Mar 2012 (estimated)
Study startApr 2012
Primary completionSep 2012
Study completionSep 2012

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 Eli Lilly and CompanyThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01545583
Sponsor's protocol ID: 14352
Other IDs: 2011-005596-17, I5V-MC-TGAA
Status last verified: Sep 2017
First submitted: 1 Mar 2012
Last updated: 19 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Safety, Tolerability and Pharmacokinetics of LY3016859 After Single Intravenous and Subcutaneous Dosing in Healthy Volunteers
ClinicalTrials.gov ID: NCT01545583
Acronym / sponsor ID: 14352
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 7 Mar 2012 (estimated)
Results: Posted 19 Jul 2018

Clinical summary

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

The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 9

Arm	Type	Receives
Placebo intravenous	Placebo comparator	Drug: Placebo intravenousPlacebo administered once intravenously
0.1 milligram (mg) LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous0.1 mg LY3016859 administered once intravenously
1 mg LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous1 mg LY3016859 administered once intravenously
10 mg LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous10 mg LY3016859 administered once intravenously
50 mg LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous50 mg LY3016859 administered once intravenously
250 mg LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous250 mg LY3016859 administered once intravenously
750 mg LY3016859 intravenous	Experimental	Drug: LY3016859 intravenous750 mg LY3016859 administered once intravenously
Placebo subcutaneous	Placebo comparator	Drug: Placebo subcutaneousPlacebo administered once subcutaneously
50 mg LY3016859 subcutaneous	Experimental	Drug: LY3016859 subcutaneous50 mg LY3016859 administered once subcutaneously

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy men and women of non-childbearing potential as determined by medical history and physical examination (PE), and:
Are reliable and are willing to make themselves available for the duration of the study, and are willing to follow site specific study procedures
Must weigh greater than or equal to (≥) 50 kilograms (kg) at time of screening and dosing
Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow blood sampling as per the protocol

Key exclusion criteria (17 listed)

Are currently enrolled in, or have discontinued within the last 60 days from a clinical trial involving an investigational drug that has not received regulatory approval for any indication, or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
Have previously completed or withdrawn from this study or any other study investigating LY3016859, and have previously received the investigational product
Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator indicates a medical problem that would preclude study participation
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or have:
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or Hepatitis B and/or positive Hepatitis B surface antigen

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
LY3016859 intravenousAdministered intravenously	Drug	0.1 milligram (mg) LY3016859 intravenous, 1 mg LY3016859 intravenous, 10 mg LY3016859 intravenous, 250 mg LY3016859 intravenous, 50 mg LY3016859 intravenous, 750 mg LY3016859 intravenous
Placebo intravenousAdministered intravenously	Drug	Placebo intravenous
LY3016859 subcutaneousAdministered subcutaneously	Drug	50 mg LY3016859 subcutaneous
Placebo subcutaneousAdministered subcutaneously	Drug	Placebo subcutaneous

Primary outcome

Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
Time frame: From baseline up to 8 weeks post dose
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.

4 secondary outcomes

Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)
Time frame: Predose up to 8 weeks post dose
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin
Time frame: Predose up to 8 weeks post dose
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859
Time frame: Predose up to 8 weeks post dose
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)
Time frame: Predose up to 8 weeks post dose

Results and safety

Results posted to the registry on 19 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo IV	12	12
Placebo SC	2	2
0.1 mg LY3016859 IV	6	6
1 mg LY3016859 IV	6	6
10 mg LY3016859 IV	6	6
50 mg LY3016859 IV	6	6
250 mg LY3016859 IV	6	6
750 mg LY3016859 IV	6	6
50 mg LY3016859 SC	6	6

Primary outcome: Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)

Time frame: From baseline up to 8 weeks post dose. Number. Unit: participants

Measure	Placebo IV n = 12	Placebo SC n = 2	0.1 mg LY3016859 IV n = 6	1 mg LY3016859 IV n = 6	10 mg LY3016859 IV n = 6	50 mg LY3016859 IV n = 6	250 mg LY3016859 IV n = 6	750 mg LY3016859 IV n = 6	50 mg LY3016859 SC n = 6
TEAE	2	0	2	3	0	0	0	1	0
SAE	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo IV	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Placebo SC	0 of 2 (0%)	1 of 2 (50%)	Not reported
0.1 mg LY3016859 IV	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
1 mg LY3016859 IV	0 of 6 (0%)	3 of 6 (50%)	Not reported
10 mg LY3016859 IV	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
50 mg LY3016859 IV	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
250 mg LY3016859 IV	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
750 mg LY3016859 IV	0 of 6 (0%)	3 of 6 (50%)	Not reported
50 mg LY3016859 SC	0 of 6 (0%)	1 of 6 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT- 5 hours, EST) study director

Eli Lilly and Company

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 LY3016859 intravenous and LY3016859 subcutaneous in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.

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 8 inclusion and 17 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: finished, as of the sponsor's last update on 19 Jul 2018. 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 Kingdom. 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 19 Jul 2018). 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?

Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE) (time frame: From baseline up to 8 weeks post dose). 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 NCT01545583.

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 19 Jul 2018.