Clinical Trials
Making the Most of your CRO Partnership
Partnership
Choosing the right CRO as a partner for your drug development programs is a vitally important step to achieving critical decision making
Artificial Intelligence Application in Early Phase Drug Development
Trends in Early Phase Drug Development
It’s the start of a new year, and our thoughts are turni
C4X Discovery: Altasciences appointed by Indivior to conduct Phase I clinical trial with C4XD’s Orexin-1 for treatment of Opioid Use Disorder
9 December 2019 – C4X Discovery Holdings plc (AIM: C4XD), a pioneering Drug Discovery company, is pleased to note the announcement that Altasciences has been selected by Indivior PLC to conduct "A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X3256) Under Fasting and Fed Conditions in Healthy Volunteers”.
Laval, Quebec, December 9, 2019 – Altasciences has been selected by Indivior PLC to conduct "A Phase I, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers", pursuant to the National Institutes of Health (NIH) Funding Opportunity Announcement RFA-DA-19-002, dedicated to the development of medications to prevent and treat opioid use disorder and overdose. The grant was made to Indivior by the NIH in fiscal year 2019, to apply scientific solutions to reverse the national opioid crisis. In March 2018, Indivior entered into a license agreement with C4X Discovery Holdings PLC (C4X) whereby Indivior obtained exclusive global rights to develop and commercialize INDV-2000 (C4X_3256).
Quiz – All About Investigational New Drug Submission
Test Your Knowledge —Investigational New Drugs
If you work in, or around, the early phase drug development landscape, you are likely aware of the requirements for an investigational new drug (IND) package.
Renal Impairment Study Designs Trends, Optimization, Adaptive Approach. A Review.
Drug-Drug Interactions - What you Should Know
the study of Drug-Drug Interactions
ISSUE NO. 10 — Tackling Early-Phase Development Challenges with Effective First-in-Human Studies
First-in-Human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines. Their purpose is to study the human pharmacology, pharmacokinetics (PK) and pharmacodynamics (PD), tolerability, and safety of an investigational medicinal product (IMP) having already gone through preclinical studies, and to evaluate how the effects translate from animals to humans.
They may also include the collection of data on food or drug interactions, different age groups or gender, proof of concept, and relative bioavailability of different formulations.
In Issue 10 of The Altascientist, we review:
- Designing a FIH trial
- Key aspects of FIH trial designs
- Access to patient populations
- Integrating adaptive designs into FIH trials
- A single-center, randomized, placebo-controlled, double-blind, adaptive, FIH study case study
Clinical Case Study - First in Human
Clinical Case Study - Randomized Cross Over Efficacy Study Metabolic Disorder
Clinical Case Study - Evaluting Abuse Potential (HAP) neuropathic pain medication