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Phase 1 Completed N=56 Randomized Double-blind Treatment

A Study of LY3016859 in Healthy Volunteers

Healthy Volunteers
Source: ClinicalTrials.gov NCT01545583 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE) — 2; 0; 2; 3 participants

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
2; 0; 2; 3; 0; 0
SECONDARY
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)
41271; 8573; 2515; 4444; 9718; 4286
SECONDARY
Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin
349927; 331408; 280500; 296022; 405745; 379401
SECONDARY
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859
36; 399; 3812; 18467; 106967; 271167
SECONDARY
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)
9967; 235759; 2769626; 23180633; 81450520; 1054034

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01545583). 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.

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