NCT00002316 is a Phase 1 clinical trial of Lobradimil in Meningitis, Cryptococcal, sponsored by Alkermes, Inc..

Who is sponsoring NCT00002316?

NCT00002316 is sponsored by Alkermes, Inc..

What drugs are being tested in NCT00002316?

Interventions in NCT00002316: Lobradimil, Amphotericin B.

What condition does NCT00002316 study?

NCT00002316 studies Meningitis, Cryptococcal, HIV Infections.

Is NCT00002316 still recruiting?

NCT00002316 is currently completed. Last updated 23 June 2005.

Last reviewed 2005-06-23 · How we verify

NCT00002316

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study to Evaluate the Safety and Tolerance of RMP-7 Administered With Amphotericin B to Patients With HIV Infection and Cryptococcal Meningitis

Completed Phase 1 Last updated 23 June 2005

What this trial tests

Phase 1 trial testing Lobradimil in Meningitis, Cryptococcal. Completed.

Quick facts

Lead sponsor	Alkermes, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Masking	double
Primary purpose	treatment
Sites	11 locations across United States

Drugs / interventions tested

Lobradimil — full drug profile →
Amphotericin B (AMPHOTERICIN B) — full drug profile →

Conditions studied

Meningitis, Cryptococcal — all drugs for Meningitis, Cryptococcal →
HIV Infections — all drugs for HIV Infections →

Sponsor

Alkermes, Inc. — full company profile →

Who can join

18 and older, any sex, with Meningitis, Cryptococcal or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety of escalating doses of RMP-7 administered in persons with HIV infection and cryptococcal meningitis and to determine the MTD of the drug. To evaluate the pharmacokinetics, including cerebrospinal fluid (CSF) penetration, of amphotericin B when administered with RMP-7.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Systematic Review of Molecular Imaging Agents Targeting Bradykinin B1 and B2 Receptors.
Lau J, Rousseau J, Kwon D, Bénard F, et al · · 2020 · cited 29× · PMID 32824565 · DOI 10.3390/ph13080199
IL-17 Receptor Signaling Negatively Regulates the Development of Tubulointerstitial Fibrosis in the Kidney.
Ramani K, Tan RJ, Zhou D, Coleman BM, et al · · 2018 · cited 24× · PMID 30405320 · DOI 10.1155/2018/5103672

Verify or expand the search:

Other Alkermes, Inc. trials

Trials by the same sponsor.

NCT06555783 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 · Phase 2 · completed
NCT06358950 — A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201) · Phase 2 · completed
NCT05547100 — Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan · Phase 1 · completed
NCT05019105 — Phase 1 ALKS 1140 in Healthy Adults · Phase 1 · terminated
NCT04987658 — Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00002316 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alkermes, Inc.
Last refreshed: 23 June 2005

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002316.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing