Phase 1 N=74 A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Osteopenia
Primary: Number of Participants With Adverse Events — 9; 4; 4; 1 Participants
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Phase 1 N=24 A Study to Evaluate the Effect of Romosozumab (AMG 785) on Bone Quality of the Forearm in Postmenopausal Women With Low Bone Mass
Osteopenia
Primary: Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius — -1.16; 0.16; -1.03; -1.03 percent change
Phase 1 N=29 A Study of LY3031207 in Healthy Subjects
Healthy Volunteers
Primary: Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE — 0; 0; 0; 0 Participants
Phase 1 N=25 Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers
Healthy
Primary: Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin — 29.22; 26.08…
Phase 1 N=30 Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Cocaine Use Disorder
Primary: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative — .34; .24; 4.31; 3.9 Cocaine Choices
Phase 1 N=17 Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma
Melanoma · Skin Cancer
Primary: Maximum Tolerated Dose (MTD) — 5 mg
Phase 1 N=64 Gardasil Vaccination in Post Stem Cell Transplant Patients
Gardasil Vaccine · Stem Cell Transplant · Immunogenicity
Primary: Percentage of Subjects Who Developed Antibody Response to the Vaccine. — 18; 20; 20 Participants
Phase 1 N=20 Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors
Cancer · Neoplasms
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Parts 1 and 2 — 1; 3; 2; 5 Participants
Phase 1 N=45 Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers
Reticulocyte Count
Primary: AUC (0-1176 Hours) — 206974.500; 657417.000; 827904.750; 1360020.000 pg*hr/ml
Phase 1 N=57 The Study of PK, PD, Safety of Multiple Intravenous Injections of BCD-066 and Aranesp in Healthy Volunteers
Healthy
Primary: AUC(0-72) — 328215.65; 290827.12 pg/ml·h
Phase 1 N=28 A Study of LY2216684 in Healthy Participants
Major Depressive Disorder
Primary: Change From Baseline to 10 Hours in Power of Attention Composite Score — 67.82; 52.77; 20.6; 6.78 minutes
Phase 1 N=28 A Bioequivalence Study of the Lu AA21004 20 mg and 2×10 mg Tablets
Healthy Adult Participants
Primary: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004 — 299.3; 301.1 hour*nanogram per…
Phase 1 N=25 A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Diabetes Mellitus, Type 1
Primary: Concentration of Epinephrine — 157.2; 196.5; 607.5; 525.2 picomole per liter (pmol/L)
Phase 1 N=10 Targeted Chemotherapy Using Focused Ultrasound for Liver Tumours
Liver Tumour
Primary: Concentration of Total Intratumoral Doxorubicin in Liver Tumour (Biopsies) Following Targeted Release of Doxorubicin From ThermoDox® ('Drug') Using Mild Hyperthermia…
Phase 1 N=28 To Investigate the Gastrointestinal Behaviour of Two Triple Combination Products in Healthy Male Volunteers
Common Cold
Primary: Mean Time to Onset of Gastric Emptying — 1.107; 8.534 minutes