Hormonal Mechanisms of Sleep Restriction - Axis Study

Summary

The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Conditions

• Sleep Restriction

Interventions

DRUG

Ketoconazole Pill

Ketoconazole pill is taken 4 times per Inpatient Stay

DRUG

Ganirelix

Ganirelix subcutaneous injection is administered twice per Inpatient Stay

DRUG

Dexamethasone

Dexamethasone Pills is taken twice per Inpatient Stay

DRUG

Dexamethasone Injection

Dexamethasone IV injection is given twice per Inpatient Stay

DRUG

Cosyntropin Injectable Product

cosyntropin injection is given twice per Inpatient Stay

DRUG

Recombinant Human Luteinizing Hormone

Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit

DRUG

Hydrocortisone Injection

Hydrocortisone IV push is given twice per Inpatient Visit

DRUG

Gonadorelin

Gonadorelin IV injection is given twice per Inpatient Stay

DRUG

Corticorelin

Corticorelin IV injection is given twice per Inpatient Stay

DRUG

Placebo oral capsule

Placebo for ketoconazole are given 4 times per Inpatient Stay

DRUG

Saline Solution

Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay

DRUG

Saline Solution for Injection

Saline Solution (placebo) for ganirelix subcutaneous injection

Sponsors & Collaborators

• Peter y. Liu

  lead OTHER

Principal Investigators

• Peter Liu, MD, PhD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

22 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-08

Primary Completion

2020-10-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations